Strategic Project Lead

4 weeks ago

Gurgaon, Haryana, India Naari Pharma Pvt Ltd. Full time

Naari Pharma Pvt Ltd. is a dynamic organization seeking a highly experienced Strategic Project Lead - Clinical Operations to join our team.

The ideal candidate will possess a minimum of 16-17 years of experience in CRO management, vendor approval, and clinical project contracts. A strong background in handling regulatory queries and preparing clinical overviews and study reports is essential.

This role offers a competitive salary of $120,000 per annum, commensurate with experience.

About the Role:

We are looking for an exceptional individual who can excel in coordinating between internal teams, external vendors, and regulatory bodies to ensure timely execution of clinical and bioanalytical phases. The successful candidate will be responsible for managing budgets and ensuring compliance with SOPs, as well as negotiating with vendors to guarantee smooth project execution.

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

About You:

  • You have a proven track record of 16-17 years in CRO management, vendor approval, and clinical project contracts.
  • You possess expertise in handling regulatory queries and preparing clinical overviews and study reports.
  • You have exceptional coordination and communication skills for cross-functional collaboration.
  • You are adept at managing budgets and ensuring compliance with SOPs.
  • You have negotiation skills to work with vendors and ensure timely project execution.

What We Offer:

  • A competitive salary of $120,000 per annum, commensurate with experience.
  • A dynamic and collaborative work environment.
  • Ongoing professional development opportunities.

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