Manager - Global Trial Manager
Position: Global Trial Manager
Location: Mahakali - Office, Mumbai
Company: Sun Pharmaceutical Industries Ltd
Job Summary:
Sun Pharma is seeking a Global Trial Manager for its clinical development team in Mumbai. The Global Trial Manager will assist the Global Trial leader in managing global, regional, or complex local clinical trials. This role will provide operational oversight from study start-up, execution, close-out, and report finalization. Responsibilities include reviewing study plans, monitoring progress, data quality, and coordinating tasks and timelines to ensure the project stays on track.
Responsibilities:
Oversight of CRO/Other Vendors and Study Management:
Oversee CRO pre-site selection, site initiation, interim close-out, and co-monitoring visits to ensure protocol compliance and good site performance.
Manage CROs and vendors to ensure project requirements are met and activities are on time and of high quality.
Monitor project progress and resource allocation to ensure timely and on-budget completion.
Review operational aspects of trial activities and clinical protocols, overseeing trial implementation.
Utilize systems and technologies to document and track study progress.
Assist in reviewing clinical protocols, amendments, informed consents, CRF/source document design, and related documents.
Oversee TMF management and ensure necessary reviews of TMF documents.
Perform data reviews according to data review/monitoring guidelines (CTMS, EDC, IVRS).
Work with QA to ensure CAPA documentation and resolution.
Assist in forecasting and requisitioning Investigational Product (IP) requirements.
Assist in preparing and obtaining approval for clinical trial budgets and tracking study expenses.
Collaboration with Cross-Functional Teams:
Coordinate with teams (e.g., Medical Monitor, Regulatory Affairs, Supply Chain, Statistics, Data Management, QA, CROs, and vendors) to proactively manage clinical trial execution.
Provide administrative support for meetings, presentations, and other activities related to study execution.
Interact with internal and external teams to ensure successful project completion.
Assist in managing study team meetings with both internal and external resources.
Soft Skills:
Strong problem-solving and decision-making skills to navigate complex challenges.
Stay current with industry trends and advancements in clinical trial methodologies.
Collaborative with strong interpersonal skills to build relationships with internal teams and external partners.
Contribute to a team culture that promotes continuous improvement, ownership, and professional growth.
Qualifications:
Minimum 6 years of clinical study management experience, including at least 2 years of multinational study management.
2+ years of dermatology experience.
Ability to manage delegated aspects of clinical trials and CRO/Clinical Study vendors.
Bachelor's degree in Life Sciences, Pharmacy, or Nursing.
Robust understanding of ICH/GCP and regulatory requirements.
Proficiency in MS Office (Word, Excel, PowerPoint) and other applications.
Strong clinical study/project management skills.
Excellent verbal and written communication skills.
Ability to work independently and prioritize duties.
Familiarity with Electronic Data Capture (EDC), CDMS, IRT.
Job Location:
Mahakali - Office, Mumbai
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