Global Trial Management Professional
4 days ago
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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