Clinical Project Manager
1 week ago
Clinical Project Manager
About Naari Pharma Pvt Ltd.
We are a leading pharmaceutical company seeking an experienced Clinical Project Manager to oversee our BA/BE and clinical studies. As a key member of our team, you will play a crucial role in ensuring the timely execution and compliance with protocols.
Key Responsibilities:
- Coordinate all activities related to BA/BE and clinical studies
- Monitor clinical and bioanalytical phases for adherence to study requirements
- Audit CROs, manage vendor approvals, and lead negotiations on quotes
- Identify suitable CROs, establish systems, and prepare SOPs for streamlined operations
- Handle regulatory queries and prepare departmental budgets and cost assessments
- Prepare 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
- Review service agreements to ensure they are active and relevant
- 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
- Collaborate with cross-functional departments for seamless project execution
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
What We Offer:
- Competitive salary: ₹45 Lakhs per annum (Estimated)
- Opportunity to work with a leading pharmaceutical company
- Collaborative and dynamic work environment
- Professional growth and development opportunities
Contact Us:
For more information about this exciting opportunity, please visit our website.
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