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Precision for Medicine is a global Clinical Research Organization with uniquely integrated offering which enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. Due to our continued growth we are seeking a Regulatory and Start Up Specialist based in Germany to join our growing team. Apart from the experience with regulatory submissions , for this role it's key for candidates to have contracts and budgeting negotiation experience for Germany. Apart from Germany, this position will be also covering regulatory submissions and site contract and budget negotiation in Austria and Switzerland. Essential functions of the job include but are not limited to: Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site • Review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF • May support the clinical team performing Pre-Study Site Visits. The ideal candidate will have: Minimum Required: • Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. • A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. • At least 2 years of relevant experience. Other Required: • Previous experience working as a Regulatory or Start Up specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. • Strong communication and organizational skills. • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. • Fluency in English and German Preferred: • Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. • Experience in site contract and budget negotiation. • Experience using milestone tracking tools/systems. • Ability to prioritize workload to meet deadlines • Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC …

Position Summary: Job Description Provides statistical support for all phases of clinical development. Specific responsibilities include writing and reviewing statistical sections of protocols, writing and reviewing statistical analysis plans including complex study designs, conducting statistical analyses and presenting results to project teams and sponsors, and developing SAS programs for tables, listings, figures and analysis datasets in accordance with Precision and/or sponsor procedures or study specific guidelines. Essential functions of the job include but are not limited to: • Generate and/or verify randomization schedules • Develop and review statistical methods of the clinical study protocol including complex study designs • Provide and/or verify sample size calculations. Perform or assist with advanced calculations including adaptive design • Provide input into development of case report forms (CRFs) • Author statistical analysis plans, including development of table, figure and listing shells, complex study design and late phase • Review statistical analysis plans written by other biostatisticians • Generate analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS • Perform quality control for statistical based SAS programs and other study documents (e.g., presentations and reports) • Provide or supervise programming and statistical support to supplemental or exploratory analyses for regulatory agencies or any other internal and external ad-hoc requests • Ability to serve as a biostatistical consultant to company staff globally, with understanding of varying regional perspectives • Review output across programs to ensure consistency. • Provide statistical analysis and reports to Data Monitoring Committees (DMCs) as the unblinded biostatistician • Review statistical sections of clinical study reports • Work directly with sponsors, project managers, and external vendors on statistics related project components. Interact directly with study team • Interact directly with sponsors • Lead all statistical activities for study within timelines • Independently perform budget health review on projects and review monthly invoices • Perform oversight responsibilities on projects for other biostatisticians • Assist with budget development and present at bid defense meetings • Participate in the development and maintenance of departmental procedures and standards (templates, SOPs, WIs etc.) • Review study tasks to ensure study being conducted in line with agreed budget; identify change in scope • Other duties as assigned Qualifications: Minimum Required: • Master's degree or equivalent in Statistics, Biostatistics, or related field with 10+ years experience; PhD degree in Statistics, Biostatistics, or related field with 7+ years experience Other Required: • Experience with SAS • Knowledge of industry standards such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines • Broad knowledge and superior understanding of advanced statistical concepts and techniques Preferred: • Experience with Oncology and rare diseases • Broad experience with late phase and/or submissions • Experience in consulting with clients on study design • Superior understanding of a specific therapeutic area and/or statistical methodology (eg, adaptive design, missing data) Skills: • Mastery of statistical principles underlying clinical trials • Mastery of SAS programming skills and familiarity with other packages • Outstanding statistical skills • Excellent consultative skills • Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines. • Excellent communication and interpersonal skills to effectively interface with others. • Excellent problem-solving skills • Excellent presentation skills Competencies: • Sound judgment/decision making • Ability to establish and teach others to maintain effective working relationships with coworkers, managers and clients • Service oriented, accountable and flexible • Competency in written and spoken English • Follow and train others on applicable regulations, including FDA, ICH, and Precision Policies and Procedures Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact …

Precision for Medicine is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages. Our CRAs work with a manageable study portfolio, allowing them to build deep protocol and site knowledge rather than spreading their focus across too many studies. With reasonable travel expectations, accessible line management and a smaller CRO environment, experienced CRAs have the autonomy to make decisions, influence how studies are delivered and see the impact of their work. Precision for Medicine is recruiting a Clinical Research Associate II / Senior Clinical Research Associate to join our full-service team in Poland . This position is fully home based About you: • You are an experienced independent monitor who takes ownership of your sites and does not wait to be told what needs attention. • You understand what really matters for patient safety, data integrity and study delivery, and can distinguish critical risks from administrative noise. • You build credible relationships with investigators and site teams while remaining confident in addressing difficult or sensitive issues. • You identify emerging risks early, escalate appropriately and come with solutions, not just problems. • You are organized and well prepared, able to manage competing priorities across your sites without compromising quality. • You communicate clearly with CTMs and study teams and can confidently represent the site perspective in project discussions. • You take responsibility for the quality and outcomes of your work. How we will keep you busy and support your growth: You will independently manage and monitor investigative sites, taking ownership of site performance, quality and risk identification from site initiation through close-out. You will partner closely with CTMs and study teams to anticipate issues, drive timely resolution and ensure studies are conducted, recorded and reported in accordance with the protocol, SOPs, ICH-GCP and applicable regulatory requirements. You may also interact directly with clients and support site payment activities. Depending on your experience, you may have the opportunity to mentor less experienced CRAs and contribute your expertise to study-level discussions and process improvements. Qualifications: Minimum Required : • 3+ years of independent monitoring experience within the CRO or pharmaceutical industry • Independent monitoring experience in oncology clinical trials Other Required : • Availability for domestic travel, including overnight stays, which may constitute up to approximately 50–60% travel commitment; occasional international travel may be required • Fluency in Polish and English Preferred : • Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline • Experience monitoring complex early-phase oncology studies, including Phase I and/or CAR-T trials Why Precision for Medicine? Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology. Precision for Medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway. We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive changes for the company. Please, apply in English. LI-EK1 #LI-Remote Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com . …

Precision for Medicine is looking for a Site Contracts Manager to join our European Team. The position can be covered fully remotely from Poland, Slovakia, Serbia, Romania or Hungary. Position Summary: Review, draft, negotiate and track a variety of legal agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements. Work closely with Clinical Operations study team and play a key role to ensure deliverables are in alignment with defined study timelines. Essential functions of the job include but are not limited to: • Review, draft and negotiate a variety of agreements including master services agreements, site contracts, consulting agreements, vendor agreements, confidentiality agreements, and other client contracts. • Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues. • Ensure adherence to company policies, procedures and contracting standards. • Update relevant study team members regarding the status of contract negotiations and execution. • Establish, track, report and manage site contract metrics. • Support the maintenance of contract files and databases, including contract archiving. • Assist in designing and implementing policies and procedures to affect the timely execution of contracts. • Recognize where processes can be improved and take corrective action. • Other tasks as assigned. Qualifications: Minimum Required: • Graduate, postgraduate, 4-year college degree • Experience in a CRO/healthcare field • Relevant experience in drafting, reviewing and negotiating site Clinical Trial Agreements, Vendor Contracts and Site Budget negotiations, but no less than 5 years’ experience. • Experienced leading interactions with Study Teams and Sponsor Preferred: • Bachelors in law, scientific fields, business administration or equivalent degree • Excellent organizational and communication skills and attention to detail • Knowledgeable on setting up Contracting Plans - Guides for CTA & Budget negotiations • Successful handling relationship study team and/or with CRAs/Start-up Associate/(S)BSCA to meet study timelines Skills and Competencies: • Possesses strong organizational/written communication skills and the ability to multi-task and prioritize in a fast-paced environment. • Executes time-sensitive matters while maintaining accuracy and attention to detail. • Exhibits high self-motivation and is able to work and plan independently as well as in a team environment. • Demonstrates a high degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills. • Displays sound business judgment and a proactive, independent work style. • Proficient in MS Office software programs and computer applications • Handles sensitive issues with discretion. • Works well independently and cooperatively with others to achieve common goals in a virtual environment. • Develops, maintains, and strengthens relationships with others inside or outside of the organization who can provide information, assistance, and support. LI-TB1 LI-Remote Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com . Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at myHR@precisionmedicinegrp.com so we can investigate and take appropriate action. Candidates must be legally authorized to work in the country of employment without employer sponsorship.

Are you an experienced full service Project Manager in the field of clinical trials who’s engaged in addressing the challenges facing the research and development of novel compounds in Oncology. Are you passionate about impacting the health and lives of patients around the world? Do you take a consultative approach to trial management, proving to be a valuable partner in trial operational delivery? Precision for Medicine are looking to hire a Clinical Project Manager / Senior Clinical Project Manager with experience in Oncology who have managed full service clinical trials within a CRO setting to join our global team. In this pivotal role you will have full service oversight for clinical projects across global/regional (ph I-IV) trials, within Oncology. Accountable for clinical project delivery, oversight of all functional departments, and ensuring agreed timelines, scope, cost and quality. Involved in all study stages, including proposal strategy, development, costing, and bid defence, and seeing studies through the full cycle to completion, managing the client relationship, project team and budget and timelines throughout. You will work in a cross-functional team with both internal and external stakeholders, driving quality and coordinating the study team. We offer an amazing high-energy, dedicated, collaborative team members who enjoy a challenge, thrive in the details and flourish in dynamic environments. If you are no stranger to taking charge and seek positive teamwork to deliver extraordinary work, we have an opportunity for you. How we will keep you busy and support your growth: • You will independently lead clinical projects in accordance with the study budget and scope of work. You will use your strong interpersonal and organizational skills to set and achieve objectives in the execution of the projects; both contracted objectives and financial objectives. You may be called upon to run international trials as well. • Serve as the primary point-of-contact liaison with the client to provide excellent customer service, including participation in proposal activities and client presentations • Liaise with Project Team and senior management of both Precision and sponsors, including C level • Handle and lead all aspects of a clinical research trial or trials • Total project management for all functional areas including data management, safety, clinical, medical monitoring and biostatistics, etc. • Prepare project status updates for clients and management; identifying key deliverables and performance metrics of success and escalation. • Serve as an active member of the Project Team with the goal to contribute towards efficient management and execution of trials • Prepare and reviews protocols and other study documentation such as project plans, inform consents, site contracts and budgets Requirements: • Degree or similar related life science qualification, or equivalent combination of education and experience. • Previous experience in a full service/global Project Management role working in the CRO industry is essential. • Extensive experience working within Clinical Operations position within a CRO, and at least 4 years full service Project Management experience in a clinical trial setting working for a Clinical Research Organisation. • Experience managing studies within Oncology • Working understanding of GCP/ICH guidelines and the clinical development process • Ability to drive and availability for domestic and international travel including overnight stays • Be able to communicate effectively in the English language both written and spoken • Strong presentation skills • Proven computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS) • Proven ability to develop positive working relationships with individual and teams internally and externally • Demonstrated core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan Precision for Medicine's uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical authorities, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology. We are a people focussed CRO with a supportive and collaborative environment which promotes work life balance and encourages team development. We invite you to learn more about our growing organization serving our clients that are researching ground-breaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, …

Precision for Medicine is a global Clinical Research Organization with uniquely integrated offering which enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. Due to our continued growth we are seeking a Regulatory and Start Up Specialist based in Spain to join our growing team. Apart from the experience with regulatory submissions, for this role it's key for candidates to have contracts and budgeting negotiation experience for Spain and be fluent in Portuguese language. Essential functions of the job include but are not limited to: • Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site • Review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF • May support the clinical team performing Pre-Study Site Visits. The ideal candidate will have: Minimum Required: • Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. • A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. • Demonstrated experience in contracts and budgeting negotiation experience, on top of experience related to regulatory submissions. • Fluency in English and Portuguese Other Required: • Previous experience working as a Regulatory or Start Up specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. • Strong communication and organizational skills. • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. Preferred: • Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. • Experience using milestone tracking tools/systems. • Ability to prioritize workload to meet deadlines • Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science. LI-TB1 LI-Remote Any data provided as a …

Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. As our company continues we grow we are seeking a Start Up Specialist to join our growing team. For this position, we are open to candidates at all levels, who have acquired some Site Start Up experience gained from within a Clinical Research Organisation. We are open to candidates located in Hungary, Poland, Serbia, Slovakia or Romania with fluency in Hungarian. Essential functions of the job include but are not limited to: • Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. • Interaction with CA/EC for study purposes and handling responses to the CA/EC. • Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership • Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. • Partner with the assigned site CRA to ensure alignment in communication and secure site • review and manage collection of essential documents required for site activation/IMP release. • Customize country/site specific Patient Information Sheet and Informed Consent Form. • Responsible for/facilitates the translation and co-ordination of translations for documents. • Maintain communication with other key functions participating to country start up e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. • Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. • When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. • May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. • Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. • Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF • May support the clinical team performing Pre-Study Site Visits. The ideal candidate will have: Minimum Required: • Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. • A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. • Demonstrated experience as a Regulatory or Start Up specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Other Required: • Strong communication and organizational skills. • Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. • Must be fluent in Hungarian and English, as you will be supporting Hungarian sites Preferred: • Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience. • Experience using milestone tracking tools/systems. • Ability to prioritise workload to meet deadlines • Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science. LI-OS1 #LI-Remote Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to …

Precision for Medicine, Oncology and Rare Disease is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages. We are now recruiting Clinical Research Associates (different seniority levels) to join our team in Germany. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will focus on an average of one to two studies setting you up to be a protocol expert. Travel is reasonable and your work/life balance will benefit as a result. Most meaningfully - your voice will be heard. Working in a smaller CRO allows you to have influence and impact when it matters most and support from direct line management. About you: • You are calm, thoughtful, and responsive when things don’t go as planned. • You are well-prepared, whether it be for an investigator meeting, site visit or project team update, always staying two steps ahead of the game. • You find quick and creative ways of overcoming difficulties. • You have an impeccable eye for detail. • You identify potential study risks and propose solutions on how to mitigate them. • You take responsibility in the quality and outcomes of your work. • You are adept at handling conflict by using tried and true resolution strategies. How we will keep you busy and support your growth: You will monitor and own the progress of clinical studies at investigative sites and ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards. You will coordinate all necessary activities required to set up and monitor a study (i.e., identify investigators; helping prepare regulatory submissions, conducting pre-study and initiation visits, etc.). Qualifications: Minimum Required : • Graduate or postgraduate degree with a concentration in a scientific or healthcare discipline • At least 6 months of experience as a CRA in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. Site management or equivalent experience in clinical research. Other Required : • Excellent communication and organizational skills are essential. A team player. • Evidence of a client focused approach. • Availability for domestic travel including overnight stays, which may constitute up to approximately 50-60% travel commitment (international travel may be required for some senior level positions) • Fluency in English and German • Experience in oncology Preferred : • Study start up activities experience • CAR-T or FIH - phase III • Medical device experience LI-EK1 #LI-Remote Please, apply in English. Precision for Medicine, Oncology & Rare Disease is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology. Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway. We invite you to learn more about our growing organization serving our clients that are researching groundbreaking cancer therapies. We strive to ensure employees feel appreciated for the contributions they make every single day. You will provide input and have your ideas valued and nurtured, impacting positive change for the company. Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice . Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at myHR@precisionmedicinegrp.com . Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or …

Precision for Medicine is looking for an experienced Clinical Trial Manager to join our growing team. Candidates can work remotely in Hungary, Poland, Romania, Serbia or Slovakia. Precision for Medicine is a precision medicine CRO. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas. You will be the hub of central intelligence for the studies you will be managing and will lead CRAs and oversee all clinical aspects of your study across multiple countries, ensuring timeline adherence and scope, whilst ensuring quality delivery. We encourage high-energy, dedicated professionals who enjoy a challenge, thrive in the details and flourish in dynamic environments to explore this opportunity. We are addressing the challenges facing the research and development of novel compounds in Oncology and are dedicated to positively impacting the health and lives of patients around the world. If you take a consultative approach to trial management, proving to be a valuable partner in the trial operational delivery process, don't miss exploring working with us. About You: • You love having responsibility and a say in how clinical trials are run • You plan ahead, but have alternative options and a flexible approach • You are client focused • You are well organised and able to manage timelines and shifting priorities, without sacrificing quality. • You communicate clearly, often and concisely and know that your role is crucial in keeping the trial running smoothly • You are a master at identifying any risks that threaten projects and handle them resolutely • You thrive and work with autonomy and ownership to deliver successful outcomes The day-to-day role, and how we will support your continued growth: • Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out • Successful execution of assigned trials and ensuring completion of trial deliverables • Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members • Mentoring and training of team members • Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor • Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities • Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction Qualifications: Minimum Required: • Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in the field of oncology Other Required: • Demonstrable experience leading clinical aspects of your studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated 'clinical lead' role). • Significant clinical trial management experience in the area of oncology • Experience with CAR-T and Radiopharmaceuticals would be a strong plus • Working knowledge of GCP/ICH guidelines and the clinical development process • Availability for domestic and international travel including overnight stays • Must be able to communicate effectively in the English language Skills: • Demonstrated computer skills (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS) • Demonstrated ability to develop positive working relationships with internal and external organizations • Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan Competencies: • Demonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ability to implement Precision medicine is revolutionizing the attack on cancer—and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials. Ultimately, we deliver robust insights that inform real-time decisions—and optimize the oncology development pathway. LI-Remote LI-TB1 Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy …

Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease. Precision for Medicine are recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join our growing global team. As a Regulatory Manager, you will provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organised, quality regulatory submissions in compliance with applicable regulations. You will be responsible for coordinating and preparing regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. Essential functions of the job include but are not limited to: • Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards • Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs • Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated. • Assist in development of Regulatory Affairs Specialists and other operational area staff, as required • Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information • Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions. • Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval • Provides ICH GCP guidance, advice and training to internal and external clients • Serve as representative of Global Regulatory Affairs at business development meetings The ideal candidate will have the following: Minimum Required: • Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline • 5 years Regulatory experience required for the Manager level and 7 years Regulatory experience required for the Senior Manager Regulatory level • Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialised knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions. • Candidates must have regulatory affairs experience working for a CRO or within the Pharmaceutical Industry, and have experience leading Clinical Submissions • Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy • Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied • Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development • Availability for domestic and international travel including overnight stays Competencies • Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities • Understanding of financial management • Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates • Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills • Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment • Motivates other members of the project team to meet timelines and project goals • Flexible …

Due to our continued growth, Precision for Medicine is looking for a Senior Feasibility Associate/Feasibility Manager to join our European team. This position can be covered fully remotely in UK, Spain, Hungary, Poland, Romania, Serbia or Slovakia. The final title, Senior Feasibility Associate or Feasibility Manager, will be determined based on the successful candidate’s experience and demonstrated level of responsibility. Position Summary: The Feasibility Manager is a member of Precision for Medicine’s expert Feasibility Department and is responsible for delivering evidence-based feasibility assessments across pre-award, post-award, rescue, and stand-alone engagements. The role combines clinical and scientific interpretation with operational intelligence and data analysis to develop country, site, patient-pool, and recruitment recommendations. The Feasibility Manager partners with Business Development, Clinical Operations, Medical, and other cross-functional stakeholders to ensure that recommendations are scientifically credible, operationally realistic, and clearly communicated. The successful candidate will manage assigned feasibility deliverables, present analyses and recommendations to internal stakeholders and clients, and contribute to strategic initiatives that strengthen Precision for Medicine’s feasibility capabilities and competitive position. Key responsibilities • Lead or contribute to feasibility assessments for client requests for proposals. • Review clinical protocols, study assumptions, client information, and operational plans for United States and global clinical trials. • Conduct and synthesise competitive landscape, historical recruitment, standard-of-care, treatment landscape, epidemiology, country, site, and patient-pool analyses. • Translate evidence into clear country, site, enrolment, and operational recommendations. • Develop logical, transparent rationales for assumptions and identify important data limitations and feasibility risks. • Present feasibility methods, findings, recommendations, and supporting rationale to Business Development colleagues, proposal teams, and clients. • Collaborate with internal colleagues, external consultants, data partners, investigators, and sites to gather and interpret feasibility information. • Plan, coordinate, and analyse targeted site and investigator outreach, as appropriate. • Participate in bid-defence meetings and client discussions. • Contribute to the continued development of feasibility methods, data sources, tools, templates, and best practices. Share knowledge and support the development of colleagues within the Feasibility team. • Work effectively across functions, therapeutic areas, and geographic regions. • Contribute to initiatives that strengthen Precision for Medicine’s scientifically driven approach and client offering. Required qualifications and experience: • Bachelor’s degree in life sciences or a related discipline. • At least two years of relevant experience in clinical trial feasibility, clinical operations, site intelligence, epidemiology, clinical research, or a related area. • Experience conducting or contributing to clinical trial feasibility analysis and site or country identification. • Ability to interpret clinical, scientific, epidemiological, and operational information and develop clear recommendations. • Professional proficiency in written and spoken English. • Equivalent combinations of education, qualifications, and relevant experience may be considered. Preferred qualifications and experience • Postgraduate degree in life sciences, public health, epidemiology, data science, or a related discipline. • Experience supporting global clinical trials. • Experience in oncology, rare disease, or other complex clinical-development programs. • Experience presenting analyses and recommendations to clients or senior stakeholders. • Familiarity with clinical-trial intelligence, epidemiology, site-performance, or claims and real-world-data platforms. Skills • Strong analytical and critical-thinking skills, with the ability to synthesize multiple evidence sources. • Ability to develop and communicate a clear rationale for feasibility assumptions and recommendations. • Strong attention to detail while maintaining awareness of the overall study strategy. • Ability to manage multiple concurrent deliverables, stakeholders, priorities, and deadlines. • Excellent written, verbal, and presentation skills. • Advanced proficiency in Microsoft Excel, PowerPoint, and Word. • Confidence working with web-based data, intelligence, and analytics platforms. • Strong ownership of deliverable quality, accuracy, and timeliness. • Collaborative working style and ability to operate effectively in a matrix environment. • Ability to work independently while seeking input and escalation appropriately. • Working knowledge of ICH-GCP principles. Precision for Medicine brings together clinical-trial …

Position Summary: The Principal/Senior Clinical Scientist is responsible for leading the clinical science function across assigned Oncology, Rare Diseases, and/or Autoimmune clinical development programs, from study start-up through database lock, in alignment with project scope, timelines, and quality expectations. Applicants must have Oncology experience (see Minimum Required Qualifications). In this role, you will provide scientific and indication-specific expertise to support the collection, review, and interpretation of clinical trial data. Working as a key member of Precision for Medicine's cross-functional data review team, you will apply clinical knowledge and scientific insight to identify, evaluate, and resolve data issues, manually (not just programmed exclusion listings outputs) while also leveraging data review tools and platforms, ensuring clinically accurate and high-quality data while protecting participant safety. As a subject matter expert, you will leverage current clinical practice guidelines, standards of care, and disease-area expertise to support complex, scientific and clinical data review and data cleaning activities. You will play an active role in supporting study deliverables and collaborating with internal and external study team members to ensure successful study execution within scope, budget, and timelines. Key Responsibilities: • Serve as a functional team lead, implementing Clinical Science services per study scope of work on assigned projects from study start through database lock ensuring delivery of high-quality outcomes within agreed timelines and budgets. • Perform holistic individual participant data review, and aggregate participant data review, utilizing a combination of Precision’s proprietary and non-proprietary data review tools and platforms, while applying clinical and scientific judgment based on therapeutic area and indication specific expertise to support data capture, data review and interpretation, query management, and clinically relevant data cleaning activities. • Serve as the scientific and clinical data subject matter expert for study teams, guiding eCRF design, data capture requirements, edit checks, completion guidelines, EDC UAT, and ongoing clinical data review and cleaning to ensure protocol-compliant, high-quality data as studies progress. • Support Risk Based Quality Management (RBQM), identifying and addressing study risks, trends and issues, while partnering with cross-functional teams participating in the risk review processes and meetings. • Collaborate with Medical Monitoring including oversight of Medical Monitor review of participant data and data review findings. • Provide protocol review from a scientific operational perspective. • Working knowledge of Oncology and clinical research standard criteria (e.g.: CTCAE, ASTCT, RECIST 1.1., Lugano, ICANS, etc.). • Support Project & Financial Management invoicing and out of scope management. • Collaborate with Clinical Science management regarding resource needs. • Oversee &/or develop and maintain Clinical Science project related plans, guidelines, and trackers, programming specifications for data review tools/outputs, etc. • Ensure applicable eTMF documentation related to Clinical Science is maintained accurately. • Participate in internal and external study-specific team meetings &/or presentations as applicable including facilitating, coordinating and managing Medical Data Review Meetings. • Contribute to study-level strategy, data review processes, and continuous improvement initiatives. • Support business development needs (e.g.: bid defense meeting attendance/presentations, etc.). • May conduct review of Table, Figure & Listings (TLFs) &/or clinical study reports (CSRs). Qualifications: Minimum Required: • Bachelor’s degree or equivalent combination of education/experience in science or health-related discipline with proficiency in medical terminology • Minimum of 8 years of clinical research experience or proven competencies for this position • Minimum of 3 years Oncology experience, must have been within the past 1.5 years • Minimum of 1 year of leadership experience Other Required: • High Proficiency with Microsoft Office Products (Outlook, Word, Excel, PowerPoint, Teams, OneNote). • Excellent organization skills, attention to high quality and detail, and a customer service demeanor, communication and interpersonal skills to effectively interface with others in a team setting and written and oral including presentations of data, issues, trends, escalations, etc.. • Professional use of the English language; both written and oral • Ability to occasionally travel domestically and internationally including overnight stays (up to approximately 25%). Preferred: • Medical related degree, RN, OCN, RPH, PharmD, etc. • Strongly preferred: Experience with Electronic Data Capture (EDC) systems • Database build experience • On-site experience (nurse, study …