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 Team in Heidelberg, Germany, we are looking for a

Data Manager (f/m/d)

(Reference No. C2111)

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Responsibilities

  • Act as the Trial Data Manager on assigned trials
  • Perform DM activities oversight for startup of a study including eCRF database setup, Data management plan (DMP), Data Review Plan (DRP) and performing user acceptance testing (UAT)
  • Perform DM hands on activities during the course of the study, e.g. data quality review meetings and oversight of CRO
  • Ensure necessary reconciliation activities are performed for the study in a timely manner
  • Track and report status and progress for assigned trials. Be proactive to ensure milestones are met with quality (incl. Snapshots and interim/final locks). Ensure adherence to GCP, DM standards, SOPs/WPS and process guidelines

Requirements

  • Experience working at trial sponsor and overseeing CROs preferred
  • Bachelor’s or master’s degree in life science, statistical, medical background or equivalent knowledge and experience
  • Basic SAS knowledge including data import and export
  • Minimum 5 years experience in the pharmaceutical industry working on clinical trials
  • Experience with clinical data management systems, including eCRF development with Medidata Rave
  • Profound communication skills in English, both written and verbal

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).

August 2021

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