Clinical Trial Manager
Clinical Trial Manager
Affimed
Heidelberg, Germany
Responsibilities
- Implement and execute to a high standard all aspects of assigned clinical studies from designing and planning through to conducting and reporting;
- Oversee and manage the day-to-day clinical trial activities internally, as well as externally with the CRO, vendors and external partners to monitor progress, timelines and budget, and ensure study execution is of high quality;
- Lead clinical trial team meetings with the CRO/vendor, proactively identify and manage risks, and ensure study deliverables (timelines, milestones, etc.) are on track and of good quality;
- Manage, oversee, and build effective relationships with external vendors (e.g. CROs and other third party vendors) to ensure adequate service provision in clinical trial execution; this includes the evaluation, auditing, comparison of cost proposals and final selection of service providers;
- Oversee performance of CROs and other third-party vendors, to ensure compliance with the protocol and in accordance with scope of work and in accordance with corporate timelines; identify areas of concern and escalate as appropriate;
- Oversee the management of clinical trial sites during the planning and execution of the trial: prepare training materials, train sites, ensure ongoing adherence to clinical study protocol and procedures, perform ongoing study staff training (e.g. site initiation visits, ongoing training);
- Identify potential sites and investigators, oversee site qualification to ensure suitability and readiness of investigators and trial sites;
- Review clinical trial documents (e.g. protocols, amendments, protocol information sheet/informed consent forms, Investigator Brochures, DSURs, clinical study reports, publications) in collaboration with the medical monitor and other members of the clinical development team; and review/approve study related documents (e.g. eCRFs, cohort management plans, and clinical monitoring plans);
- Manage own regulatory authority applications and oversee outsourced submissions to regulatory authorities as well as Ethics Committees; coordinate the preparation of CDAs and contracts for CROs, third party vendors and trial sites, including contract negotiations;
- Develop supportive documents such as pharmacy manuals, lab manuals, study worksheets and/or other documents needed for trial execution, and coordinate input from team members;
- Support budget planning and management of assigned clinical trial(s) and/or work packages;
- Review and approve invoices from sites, CROs and other service providers for work completed and prepare accruals.
Requirements
- BS in life sciences or a healthcare related field, MS or Ph. D. is preferred;
- Early phase development focused within Oncology;
- Strong foundation in clinical operations trial management;
- Proven leadership and relationship management;
- In depth experience with study planning, site feasibility, study conduct and close-out, database lock through generation of the clinical study report (CSR);
- Experience in CRO and third-party vendor oversight and management;
- Over 5 years of experience in clinical operations;
- Over 3 years of experience in global trial oversight;
- Deep knowledge of design, set-up and conduct of clinical studies;
- Profound knowledge of GCP and international regulations governing the conduct of clinical trials;
- Background and experience in oncology drug development and in the management of Phase 1 and Phase 2 studies is strongly preferred;
- Stakeholder/relationship management experience.
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