Senior Project Manager
18 hours ago
Naari Pharma Pvt Ltd. is a leading pharmaceutical company dedicated to delivering innovative solutions in the field of clinical studies.
Job DescriptionWe are seeking an experienced Senior Project Manager to oversee the coordination of BA/BE and clinical studies. The successful candidate will have a proven track record in managing complex projects in a regulated market, with strong negotiation, communication, and project management skills.
Key Responsibilities:- Coordinate all activities related to BA/BE and clinical studies, ensuring timely execution and compliance with protocols.
- Monitor clinical and bioanalytical 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 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, 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.
We offer a competitive salary range of $120,000 - $150,000 per annum, depending on experience, plus a comprehensive benefits package that includes health insurance, retirement plan, and paid time off.
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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