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 team, we are looking for a

Clinical Trial Manager (f/m/d)

(Reference No. C1910)

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Responsibilities

  • Implement and execute to a high standard all aspects of assigned clinical studies from designing and planning through to conducting and reporting
  • Drive and ensure compliance with SOPs, ICH guidelines, all applicable regulations, and SOPs
  • Manage, oversee, and build effective relationships with external contractors, such as CROs and other third-party vendors to ensure adequate service provision in clinical trial execution including the evaluation, auditing, comparison of cost proposals and final selection of service providers
  • Contribute to the development and review of clinical trial documents (e.g., protocols, ICF, eCRF, site manuals, clinical study reports)
  • Lead internal and clinical trial team meetings with the CRO, proactively identify and manage risks, and ensure study deliverables (timelines, milestones, etc.) are on track
  • Oversee and manage the day-to-day clinical trial activities internally, as well as of the CRO, vendors and external partners to monitor progress, timelines and budget, and ensure study execution is of high quality
  • Oversee the management of clinical trial sites during the lifecycle 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 of study staff)
  • Oversee vendor audits and resolve audit findings
  • Work closely with medical monitors to review trial data on an ongoing basis and to prepare materials for safety monitoring committee meetings and safety review meetings
  • Prepare and deliver presentations of trial data and progress to the clinical development team; help prepare presentations and summary reports for presentation to Management
  • Develop new SOPs and periodically revise existing SOPs, as needed; Support definition and development of internal processes

Requirements

  • Broad experience in management and oversight of CROs, trial center staff and other service providers
  • Experience in Clinical Trial Management Systems and Clinical Data Management Software
  • Leadership skills and experience in leading a cross-functional clinical trial team including internal team members as well as external representatives
  • Basic skills in negotiating contracts and budgets with CROs and other service providers
  • Project management skills
  • Excellent organizational, IT and administrative skills
  • Fluent in English and German (written and spoken)
  • Excellent and effective communication and presentation skills

Opportunity

The successful candidate will have the unique opportunity to work in a dynamic, highly motivated, multidisciplinary and collegial team.

For any queries, please contact Susanne Hering (Tel: 06221 6743675, e-mail: s.hering@affimed.com).

July 2019

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