Clinical Operations Manager

4 days ago


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

We are a leading pharmaceutical company seeking an experienced Clinical Operations Manager to oversee the successful execution of our clinical and bioanalytical studies. As a key member of our team, you will play a critical role in coordinating with internal teams, external vendors, and regulatory bodies to ensure timely completion of projects.

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.
  • Work closely with cross-functional departments to ensure smooth project execution.
What We Offer:
  • $120,000 - $150,000 per annum based on experience and qualifications.
  • An opportunity to work with a leading pharmaceutical company.
  • A dynamic and supportive work environment.
  • Professional development opportunities.
  • A comprehensive benefits package.
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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