Senior Manager

2 months ago

Gurgaon, India Naari Pharma Pvt Ltd. Full time
Who You Are:

You are a detail-oriented and proactive with experience in overseeing BA/BE and clinical studies. You excel in coordinating between internal teams, external vendors, and regulatory bodies to ensure timely execution of clinical and bioanalytical phases. With strong negotiation, communication, and project management skills, you thrive in managing complex projects in a regulated market.

How You Contribute:

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.13. Work closely with cross-functional departments to ensure smooth project execution.

What You Bring to the Team:

- 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.

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