Senior Manager of Clinical Studies

3 weeks ago


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

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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