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 in Heidelberg, Germany, we are looking for a

Clinical Trial Assistant (f/m/d)

(Reference No. C2003)

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Responsibilities

  • Support the Clinical Team in all aspects of the organization and management of clinical trials according to ICH-GCP, applicable regulations and SOPs
  • Support Trial Team in generating and updating trial related documents and manuals
  • Provide support in compilation and submission of packages for clinical trial applications to Health Authorities and Ethics Committees/Institutional Review Boards
  • Support in all administrative tasks in the context of clinical trials
  • Accurately monitor, update and maintain trial status and overview lists
  • Track status of trial-related tasks
  • Support trial-related invoicing and budgeting
  • Set up, maintain and review trial master files including supporting quality control of documents
  • Support contract management for Clinical Department: preparation of contractual documents, shipment, follow-up on return of documents, as well as filing, archiving and maintenance of internal database
  • Correspond with internal and external partners and vendors
  • Support the organization and coordination of internal and external meetings
  • Prepare and review meeting minutes
  • Collaborate with the Clinical Department in definition and development of internal processes, e.g. SOP writing

Requirements

  • Scientific degree, medical documentation officer certification or equivalent medical, scientific or pharmaceutical education
  • Long-term experience (more than 2 years) as Clinical Trial Assistant in biotech/pharmaceutical industry or at a CRO
  • Solid knowledge of ICH-GCP and regulations governing the conduct of clinical trials
  • Very good English skills, both written and spoken
  • Excellent communication skills
  • Very good organizational skills and team spirit
  • Results-oriented approach, flexible and proactive attitude towards changing needs; willingness to work on different projects simultaneously
  • Ability to systematically perform activities in a timely and accurate manner, reliability, good time management
  • Ability to work in a structured manner even under time pressure, experience in dealing with external parties
  • Ability to confidentially handle sensitive data and information
  • Very good knowledge of MS Office

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 6743 675, e-mail: s.hering@affimed.com).

August 2020

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