Clinical Project Director

5 days ago


Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full time
Job Description

We are seeking a seasoned Clinical Project Director to join our team at Naari Pharma Pvt Ltd. in [Location]. As a key member of our clinical operations department, you will oversee the management of clinical trials from start to finish.

Key Responsibilities:

  1. Coordinate all activities related to BA/BE and clinical studies, ensuring timely execution and compliance with protocols.
  2. Monitor clinical and bioanalytical phases to ensure adherence to study requirements.
  3. Audit CROs, manage vendor approvals, and lead negotiations on quotes.
  4. Identify suitable CROs, establish systems, and prepare SOPs to streamline operations.
  5. Handle regulatory queries and prepare departmental budgets and cost assessments.
  6. Prepare clinical and non-clinical overviews, including modules 2.4, 2.5, and 4, and finalize prescribing information, SmPc, and pack inserts.
  7. Review and finalize study protocols and reports, as well as biowaiver reports and clinical justifications.
  8. Review service agreements, ensuring they are active and relevant.
  9. Coordinate project contracts, invoices, and payments to ensure smooth financial operations.
  10. Manage clinical supplies for studies and represent the department in meetings, concalls, and discussions.
  11. Serve as the primary point of contact for external and internal communications.
  12. Investigate and interpret pilot study results for actionable insights.

Requirements:

  • 16-17 Years of experience in CRO management, vendor approval, and clinical project contracts.
  • Expertise in handling regulatory queries and preparing clinical overviews and study reports.
  • Exceptional coordination and communication skills for cross-functional collaboration.
  • Ability to manage budgets and ensure compliance with SOPs.
  • Adept at negotiating with vendors and ensuring timely project execution.

Estimated Salary: ₹2,500,000 - ₹3,500,000 per annum.



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