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 Assistant US (f/m/d)

(Reference No. C2106)

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Responsibilities

  • Provide support for the planning, execution, and financial aspects of assigned clinical trial(s) and/or clinical trial program to ensure the objectives are met
  • Support the Clinical Team in all aspects of the organization and management of clinical trials according to ICH-GCP, applicable regulations and SOPs
  • Ensure inspection readiness of the Trial Master File (TMF) of assigned trial(s) and/or clinical program
  • Responsibility for set up, maintenance and review of the sponsor’s trial master files including support of quality control of documents
  • Oversight of the CRO’s trial master file and review for its completeness and quality
  • Support the trial team in generating and updating of 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 within clinical trials
  • Accurately monitor, update and maintain trial status and overview lists
  • Track status of trial related tasks and trial related trainings of the study team members
  • Support trial-related invoicing and budgeting
  • 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
  • Preparation and review of meeting minutes

Requirements

  • Long-term experience as Clinical Trial Assistant in Biotech/Pharmaceutical industry or at a CRO
  • Very good knowledge of ICH-GCP and regulations governing the conduct of clinical trials
  • Over 2 years of experience with (e)TMF set-up and maintenance
  • Understanding of “inspection readiness” in terms of TMF status and study related documentation
  • Profound knowledge of DIA TMF Reference Model in current version is preferred
  • Experience in preparation of status reports and progress tracking
  • Very good knowledge of MS Office applications
  • Very good English language skills (oral and written)

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: +49 6221 6743 675, e-mail: s.hering@affimed.com).

February 2021

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