Clinical Project Manager Lead
2 days ago
Job Title: Clinical Project Manager Lead
Location: Naari Pharma Pvt Ltd.
About the RoleWe 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.
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.
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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