Senior Project Manager

18 hours ago


Delhi, Delhi, India Naari Pharma Pvt Ltd. Full time
About Us

Naari Pharma Pvt Ltd. is a leading pharmaceutical company dedicated to delivering innovative solutions in the field of clinical studies.

Job Description

We 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.
What We Offer

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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