Clinical Trial Manager

Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company which engineers targeted immunotherapies, seeking to improve patient outcomes through the power of innate immunity. Affimed’s fit-for-purpose ROCK® platform allows innate immune engagers to be designed for specific patient populations. We are developing single and combination therapies to treat cancers. 

To strengthen our highly motivated Clinical Operations Team in New York City, USA, we are looking for a

Clinical Trial Manager

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
• Minimum 5 years of experience in clinical operations
• Minimum 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
• Excellent and effective communication (both written and oral) and presentation skills
• Fluent in English (written and oral)