Senior Project Manager
8 hours ago
The Role:
We are seeking an experienced Senior Project Manager to join our team at Naari Pharma Pvt Ltd. As a key member of our clinical operations department, you will be responsible for overseeing the execution of bioanalytical and clinical studies from start to finish.
Your 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.
What You Need to Succeed:
* 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.
Salary: ₹65,00,000 - ₹80,00,000 per annum based on qualifications and location.
NB: These figures are estimates and may vary based on individual performance and company policies.
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