Global Trial Management Professional

4 days ago


Ahmedabad, Gujarat, India SUN PHARMA Full time

Sun Pharma Clinical Operations

Sun Pharma is a leading player in the generics market in the U.S and India, and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

About the Role

Sun Pharma is seeking a Global Trial Manager, Clinical operations within its clinical development Team in Mumbai. The Global Trial Manager, Clinical Operations will report into Global Trial leader, Clinical Operations.

Responsibilities

  • Oversight of CRO / other vendors and study management
  • Reviewing study plans and study documents, monitoring study progress and data quality and coordinating trial tasks and timelines
  • Ensure proper overview and communicate to teams (including on-time or high quality) of monitoring activities, data flow, data validation
  • Evaluating and monitoring the project progress and resources to ensure projects are on time and within budget
  • Reviewing operational aspects of trial activity and clinical protocols, providing oversight for trial implementation activities
  • Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS etc.)
  • Collaboration with cross functional teams

Requirements

  • Minimum 6 years clinical study management experience with at least 2 years direct multinational study management experience
  • 2 + years dermatology experience
  • Ability to manage delegated aspects of assigned clinical trials
  • Ability to manage CROs and Clinical Study vendors
  • Bachelor's level degree in life sciences, pharmacy or nursing
  • Robust understanding of ICH/GCP, and knowledge of regulatory requirements


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