Director of Clinical Operations

3 days ago


Helsinki, Uusimaa, Finland Santen Pharmaceutical Co. Full time

About the Role:

This role will support the Head of Global Clinical Quality (CQA) and Pharmacovigilance Quality Assurance in managing compliance related to cGCP, pharmacovigilance, and other related activities.

Key Accountabilities:

The successful candidate will be responsible for:

  • Supporting the development of quality processes and systems to ensure compliance with clinical study-related activities.
  • Collaborating with contract research organizations and in-house clinical development to design Clinical QA folders for all development studies.
  • Supporting preparations for and follow-up of effective audits of investigator sites, essential documents, Trial Master Files, vendors, and internal processes.
  • Providing effective oversight of systems cross-functionally in clinical research and development.
Qualifications:
  • 6+ years of experience in Clinical Quality Assurance, Quality Assurance, or Clinical Operations within Pharma or Biotechnology industry.
  • Broad knowledge of risk-based quality systems consistent with Good Clinical Practice.
  • Excellent communication and interpersonal skills.
  • Demonstrated ability to work independently and flexibly in a fast-paced, high-growth environment.

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