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At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Project Manager (Sr. PM) to join our A-team (hybrid*/remote). As a Sr. PM at Allucent, you are responsible for the overall coordination and management of clinical trials from start up through to final delivery. The trials are mainly in Oncology, Neuroscience or Immunology and Infectious Diseases. Experience in Cell and Gene Therapy is a plus. This position directs the technical and operational aspects of clinical projects - all with the sense of urgency expected of Allucent customers. In this role your key tasks will include: • Leads the project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract • Creates and executes project management plans required for project delivery and in accordance with established processes • Ensures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines. • Establishes clear communication lines and escalation pathways, communicates with project stakeholders • Provides input on study related documents such as the study protocol, CRF, Medical Review/Monitoring plan, and Clinical Study Report • Establishes requirements for and ensures project specific training plan for team activities • Leads internal and external meetings, with internal and sponsor teams, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope • Provides support for vendor identification, qualification and selection and manage vendors • Manages vendors and vendor relationships as required for project delivery • Ensures effective and efficient resource utilization across projects and programs • Produces, maintains and circulates project progress and status reports • Manages the study budget, including monthly invoicing. • Establishes project risk management plan with input from client and functional stakeholders and oversees adherence and updates throughout the project lifecycle • Proactively recognizes and addresses any changes in scope • Negotiates and influences internal and external team members in a professional manner and with successful outcomes • Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills • Ensures the Trial Master File is kept up to date and inspection ready • Serves as the primary point of communication between the sponsor and project team • Leads by example and encourages team members to develop strong solutions for clinical trial delivery • Responsible for oversight of project team delivery and communication with functional managers, including performance feedback Requirements To be successful you will possess: • Minimum Bachelor’s degree in life science, healthcare and/or business degree • Minimum 5 years of relevant work experience • Minimum 5 years of experience in drug development and/or clinical research, with at least 3 years of clinical trial project management experience • Preference for candidates with CRA experience • Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements • Demonstrates strong financial acumen, administrative excellence and analytical skills • Experience managing all phases of the full-service clinical trial delivery lifecycle (Start-up, Maintenance, Close-out). • Excellent written and verbal communication, planning, critical thinking and organizational skills, including command of English language • Representative, outgoing and client focused • Ability to work effectively in a fast-paced challenging environment with a growing company • Proficiency with various applications including, but not limited to, Microsoft Word, Excel, and PowerPoint required • Strong presentation skills • Fosters learning and the advancement and development of others • Dependable and able to take action to quickly to address urgent needs • Proactive and solution oriented • Willingly takes ownership and drives positive, collaborative results with the project team • Exercises good judgement with defined procedures and policies to determine appropriate action Benefits Benefits of working at Allucent include: • Comprehensive benefits package per location • Competitive salaries per location • Departmental Study/Training Budget for furthering professional development • Flexible Working hours (within reason) • Opportunity for remote/office* working depending on location • Leadership and mentoring opportunities • Participation in our Buddy Program as a new or existing employee • Internal growth opportunities and career progression • Financially rewarding internal employee referral program • Access to online soft-skills and technical training via ADP and …

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Clinical Data Manager (SrCDM) to join our A-team (hybrid*/remote). As a SrCDM at Allucent you lead data management activities of the Allucent Data Management (DM) department. This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meets the quality standards and regulatory requirements for analysis and reporting. This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff. In this role your key tasks will include: • Lead and serve as primary contact for DM with all relevant parties both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites) • Plan and project the resources required including management of tasks, timelines, risk and quality • Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition. • Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements • Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements • Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs) • Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed • Create training materials for EDC users and provide project-specific training as required • Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness • Create data cleaning strategy in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock) • Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data • Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance • Organize and lead Quality Review activities during study • Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA) • Manage the database maintenance, lock and close-out processes and procedure • Participate in conference calls and/or meetings with vendors and sponsors • Recognize and solve potential problems and evaluate effectiveness • Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date • Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned • Help to align data management and clinical programming best practices, standards and conventions within the company • Provide leadership, expertise and support to other department members. • Propose and support initiatives for improving efficiency • Actively support to staff learning & development within the company • Share relevant information at applicable DM departmental meetings and organize and lead DM-related meetings and discussions • Represent the company at professional meetings, webinars or seminars • Train and mentor data management staff, support in development of new training material and provide training to relevant staff • Participate in the interview process for new recruits • Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes • Contribute as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System • Assure good communication and relationships with (future) clients • Contribute to and take part in client evaluations and visits • Support in preparation of new proposals and budgets for Data Management services • Contribute to other areas of business as required Requirements To be successful you will possess: …

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Start-Up Associate II (SUA II) to join our A-team (hybrid*/remote) in Italy! The SUA coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit. In this role your key tasks will include: • Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below) • Ensure planned dates are reliable and up to date in CTMS departments/study teams • File documents in the (e)TMF for which they are the document owner • Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner • Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level • Provide relevant documents in compliance with local regulation • Support review of technical, pre-clinical and clinical reports for regulatory submissions • Interact with regulatory authorities • Prepare and compile answers for questions raised by the regulatory agencies and submit the answers • Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate • Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed • Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level • Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation • Interact with IEC/IRB • Prepare and compile answers for questions raised by the IEC/IRB and submit the answers • Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate • Assist in adapting country SIS/ISF to site-specific requirements • Provide country specific requirements to GSCM impacting site contracts’ process • Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study • Negotiate within client approved contract and budget templates and negotiation parameters • Communicate with sites and internal personnel regarding the status of contracts and contract related documents • Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable • Provide the final/draft CTA and site budget for submission, where required • Obtain site signature as well as Sponsor/Allucent signature, as applicable • Keep up to date with applicable local regulations impacting clinical trial contracts • Assist in preparing the site-specific Essential Document Package and sending to sites • Responsible for collection and first review of Essential Documents • Provide the Global Essential Document Reviewer with the collected documents for independent review • Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution • Obtain authorization for the shipment of Investigational Product to the site • Track relevant information and data in CTMS and/or other tracking tools Requirements To be successful you will possess: • Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution. • More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry. • A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines. • A thorough understanding of the drug development process • Good oral and written communications skills - fluent in Italian and English. • Attention to detail. • Able to perform well as a team member. Benefits Benefits of working at Allucent include: • Comprehensive benefits package per location • Competitive salaries per location • Departmental Study/Training Budget for furthering professional development • Flexible Working hours (within reason) • Participation in our enriching Buddy Program as a new or existing employee • Internal growth opportunities and career progression • Financially rewarding internal employee …