Clinical Project Manager Lead

2 days ago


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

Job Title: Clinical Project Manager Lead

Location: Naari Pharma Pvt Ltd.

About the Role

We are seeking a seasoned Clinical Project Manager Lead to oversee the execution of BA/BE and clinical studies. As a key member of our team, you will ensure timely project delivery, compliance with regulatory requirements, and effective coordination between internal teams, external vendors, and regulatory bodies.

Responsibilities
  • Coordinate all aspects of BA/BE and clinical studies, ensuring timely completion and adherence to protocols.
  • Monitor clinical and bioanalytical phases to guarantee compliance with study requirements.
  • Audit CROs, manage vendor approvals, and negotiate quotes to secure optimal services.
  • Identify suitable CROs, establish streamlined operations, and develop SOPs to enhance efficiency.
  • Handle regulatory queries and prepare departmental budgets and cost assessments to ensure financial prudence.
  • Prepare comprehensive clinical and non-clinical overviews, including modules 2.4, 2.5, and 4, and finalize prescribing information, SmPc, and pack inserts.
  • Review and finalize study protocols and reports, as well as biowaiver reports and clinical justifications.
  • Ensure active and relevant service agreements and coordinate project contracts, invoices, and payments for smooth financial operations.
  • Manage clinical supplies for studies and represent the department in meetings, concalls, and discussions.
  • Serve as the primary point of contact for external and internal communications.
  • Investigate and interpret pilot study results for actionable insights.
Requirements

To be successful in this role, you should possess:

  • 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.
What We Offer

We offer a competitive salary range of $120,000 - $150,000 per annum, depending on experience and qualifications. If you are a motivated and experienced Clinical Project Manager Lead looking for a new challenge, please apply.



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