Job Title:
Global Trial Manager - Clinical Operations
Company:
Sun Pharmaceutical Industries Ltd
Location:
Mahakali Office, Mumbai, India
Job ID / Posting Date:
Posted on April 21, 2025
Role Summary:
The Global Trial Manager will assist the Global Trial Leader in providing global, regional, or complex local management of clinical trials at Sun Pharma. The role involves oversight of clinical trial activities, including study start-up, execution, close-out, and study report finalization. Key responsibilities include vendor management, trial progress monitoring, and coordinating trial tasks to ensure timelines and study quality are met.
Key Responsibilities:
Vendor & Study Management:
Oversee CRO pre-site selection, site initiation, interim close-out, and co-monitoring visits to ensure compliance with protocol and regulatory requirements.
Assist in managing CROs and other vendors to ensure project requirements are met.
Evaluate and monitor project progress, resources, and budgets to ensure trials are on time and within budget.
Review operational aspects of trial activities and clinical protocols.
Assist in reviewing clinical protocols, amendments, informed consents, CRF/source document design, and training documentation.
Oversee TMF management and review documents.
Perform regular data reviews using systems like CTMS, EDC, IVRS.
Collaborate with QA to address CAPA documentation and resolution.
Assist in preparing and obtaining approval for the clinical trial budget.
Collaboration with Cross-Functional Teams:
Coordinate with teams (Medical monitor, Regulatory Affairs, supply chain, Data management, etc.) for trial execution.
Provide administrative support for meetings and presentations.
Assist in managing study team meetings with internal and external resources.
Travel:
10% travel (domestic and international).
Soft Skills:
Strong problem-solving and decision-making capabilities.
Collaborative with excellent interpersonal skills.
Contributes to a team culture focused on continuous improvement, ownership, and professional growth.
Qualifications:
Experience: Minimum 6 years in clinical study management, with at least 2 years of direct multinational study management experience.
Specialization: 2+ years of dermatology experience.
Skills:
Ability to manage CROs and clinical study vendors.
Strong clinical study/project management skills.
Proficiency in MS Office, including Word, Excel, and PowerPoint.
Understanding of Electronic Data Capture (EDC), CDMS, IRT, etc.
Excellent communication and problem-solving skills.
Education: Bachelor’s level degree in Life Sciences, Pharmacy, or Nursing.
Regulatory Knowledge: Strong understanding of ICH/GCP and regulatory requirements.
Additional Information:
Sun Pharma offers equal employment opportunities and fosters a culture of inclusion and growth for all employees.
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