Job Description
Key Responsibilities:
- Learn to draftΒ protocols, amendments, and study schedulesΒ based on client or study outline requirements.
- Assist in reviewingΒ study complianceΒ with protocols, SOPs, and regulatory guidelines.
- PrepareΒ study schedulesΒ in coordination with the Study Director (SD) or Principal Investigator (PI) and communicate work plans to lab teams.
- Participate inΒ pre-initiation meetingsΒ and other study-related discussions.
- Track study progress and updateΒ Clinical Management Systems (CMS)Β with accurate schedules.
- Serve as aΒ primary contactΒ for internal teams and clients (as applicable).
- MaintainΒ well-organized study files, including protocols, schedules, and correspondence.
- Assist inΒ monitoring in-life and analytical phasesΒ of studies, ensuring adherence to guidelines.
- SupportΒ report preparation, including data compilation, tables, and figures.
- Participate inΒ peer reviewsΒ of scientific reports and assist in data interpretation.
- ReviewΒ QAU audit reportsΒ and submit responses after SD/PI approval.
- ManageΒ client feedbackΒ and ensure report/data clarifications are completed.
- Learn to handleΒ complex projects and study designs.
- Assist inΒ report finalization and data archiving.
- Engage inΒ client visits and communicationsΒ under SD/PI guidance.
- MonitorΒ financial statusΒ of ongoing studies, including scope changes.
About the Company
A leading organization in clinical research and pharmaceutical studies, this company is committed to advancing scientific research while maintaining compliance with global regulatory standards. With a strong presence in Bangalore, it offers a dynamic work environment for professionals looking to grow in clinical trial management, regulatory affairs, and study coordination.
How to Apply
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