Clinical Trial Associate (fluent German)

Reference Number: 896027-W
Type of placement: Contract, 12 months
Location: Germany, SW - Heidelberg / Stuttgart / Freiburg

Introduction:

Our client is a dynamic and fast-paced bio-pharmaceutical company looking for a Clinical Operations Coordinator for a 12 months contract based in Freiburg, Germany. The ideal candidate should have previous experience supporting and/or coordinating European trials for a pharmaceutical company with an emphasis in phase II-III.

Main Responsibilities:

  • Coordinates the preparation and/or review of all operation trial-related documents (e.g., forms, guidelines) and site related documents (e.g., Investigator Site Files [ISF])
  • Coordinates the preparation and distribution of clinical study documentation (e.g., site communication, newsletters, pocket brochures, appendix 16 for the CSR)
  • Coordinates the delivery and inventory of study related non-clinical supplies (ordering, distribution, tracking, expiry dates management, resupplies)
  • Coordinates site contracts finalization and execution
  • Coordinates Insurance certificates for the trial in collaboration with legal department
  • Ensures completeness and maintenance of key trial information in the CTMS
  • Files, uploads and QCs documents in the different systems as needed
  • Functions as a Study Owner in the eTMF when required
  • Assists in reviewing and providing feedback of Standard Operations Procedures (SOPs), Working Instructions (WISs), Instructions, and processes
  • Performs other duties as assigned
  • Schedules and organizes functional group meetings, events
  • Support the Clinical Operations group as needed, including the Global Strategic Sourcing Group (e.g. Contracts execution and shipment, support in flexible resourcing management and Resource Request management, coordinate CRO/ESP and other providers contracts)

Qualifications and Experience:

  • Minimum of 3 years of clinical research related experience with knowledge of applicable regulations and guidelines, e.g. ICH-GCP
  • Strong experience with CTMS and eTMF and study documentation
  • Sound computer skills and familiarity with Windows-based applications (e.g., Word, Excel Power Point, and Access)
  • Team player, flexible with open communication
  • Detail oriented with the ability to handle and prioritize multiple tasks
  • Native German, plus strong English written and verbal skills.
  • Relevant working/residency permit

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