Global Trial Manager - Clinical Operation
Sun Pharmaceutical Industries Ltd.
Full time- 2+ years
- Not Disclosed
- Gurugram, India
- Post Date: Apr 03, 2024
- End Date: Jun 03, 2024
- 2+ years
- Not Disclosed
- Gurugram, India
- Post Date:Apr 03, 2024
- End Date: Jun 03, 2024
Skills:
- clinical research
- Operations
- Clinical Trial
Job Description:
Responsibilities
- Oversight of CRO / other vendors and study management-
- Oversees CRO pre-site selection and site initiation, interim close-out and co-monitoring visits to ensure compliance with protocol and regulatory requirements and to assure good site performance
- Assists in the management of CROs and other vendors to ensure project requirements are met
- 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
- User of systems and business technologies to document and track study and user progress
- Assist in review of clinical protocols, amendments, informed consents, CRF/source document design, protocol specific training documentation, administrative letters etc.
- Oversee TMF management and review TMF documents as necessary
- Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC, IVRS etc.)
- Work with QA for CAPA documentation and resolution
- Assists in forecasting of IP requirement during the study and prepare IP requisition.
- Assists in preparing and obtaining approval for clinical trial budget and for any change in the budget during the study; annual forecasting and tracking of spend.
- Assist in overall project planning and execution for clinical protocols
- This position requires approximately 10% travel to domestic and international locations
Qualification & Experience
- 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
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Salary
Not Disclosed
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Role
Manager
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Area of Practice
- Clinical Operations
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Experience
2+ years
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