Senior Manager of Clinical Studies
3 weeks ago
Job Overview
Naari Pharma Pvt Ltd. is seeking a skilled Senior Manager to oversee clinical studies and ensure timely execution.
Key Responsibilities
- Coordinate all activities related to clinical studies, ensuring compliance with protocols.
- Monitor clinical phases to ensure adherence to study requirements.
- Audit CROs, manage vendor approvals, and lead negotiations on quotes.
- Identify suitable CROs, establish systems, and prepare SOPs to streamline operations.
- Handle regulatory queries and prepare departmental budgets and cost assessments.
- Prepare 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, ensuring they are active and relevant.
- Coordinate project contracts, invoices, and payments to ensure 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
- 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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