CTA

What You Will Be Doing:

• Oversight of all trial documentation for assigned clinical trials, covering all involved adjacent affiliates within the CDC (Clinical Development Center):
  • CTA documentation to support affiliates in Health Authority and Ethics Committee submissions
  • Ensure overview of local requirements
• eTMF handling and archiving
• Timely uploading of trial documents in electronic filing system
• Compliance check of electronic filing system
• Ensure timely and adequate archiving at closeout
• Providing investigator Trial Master File (TMF) set-up and core input
• Supporting and tracking trial related payments (e.g. investigator fees), including invoice processing
• Organization of local meetings
• Supporting local safety reporting to PIs and HAs as relevant
• Supporting clinical supplies management and tracking all relevant processes
• Super user as relevant (e.g. electronic filing system)
• Other administrative tasks as relevant
• Collaboration with CDC, local clinical and Clinical, Medical and Regulatory Affairs and other cross-functional roles to ensure successful planning and conduct of clinical trials within the countries involved
• Ensure and drive consistency in eTMF handling process across CDC adjacent affiliate countries

Your Profile:

• Bachelor's degree in a scientific or healthcare-related field highly preferred.
• Prior experience or strong interest in clinical research.
• Knowledge of clinical trial processes, regulations, and guidelines.
• Excellent organizational and communication skills.
• Ability to work collaboratively in a fast-paced environment with attention to detail.