Clinical Trial Assistant
Sun Pharmaceutical Industries View all jobs
- Mumbai, Maharashtra
- Permanent
- Full-time
- Maintain, update, and organize Trial Master File (TMF) and Investigator Site File (ISF)
- Ensure essential documents meet ICH-GCP, regulatory, and sponsor requirements
- Track and manage study documents, versions, and approvals
- To update and maintain all study related trackers.
- Study Coordination
- Assist the clinical operations team in planning, initiating, executing, and closing clinical studies
- Support Clinical Research Associates (CRAs) with site management tasks
- Help with study tracking (enrolment status, visit schedules, monitoring reports, etc.)
- Assist in tracking invoice generation and payment process for all sites, clinical studies, ECs, data management vendors, etc. and maintain respective payment trackers
- Perform vendor code generation and tracking of vendors.
- Communication & Liaison
- Act as a communication link between study sites, CRAs, project managers, and vendors
- Coordinate meetings, teleconferences, and training sessions
- Draft and circulate meeting agendas, minutes, and follow-up action items.
- Regulatory & Compliance Support
- Assist in preparing documents for ethics committee and regulatory submissions as applicable
- Ensure compliance with SOPs, protocols, and regulatory guidelines
- Track site-level regulatory documents, approvals, and expirations
- Data & System Management
- Enter and update trial data in relevant trackers and other study management systems (as applicable)
- Perform QC checks on documents and data entries .
- Support query resolution by coordinating with sites and data management teams 6. Logistics & Study
- Supplies. Track and manage study supplies such as study documents, lab kits, IP shipment documents, etc. Coordinate distribution of trial materials to study sites
- Study Documentation & Reporting
- Assist in preparing status reports, trackers, logs, and summaries
- Maintain study dashboards (screening logs, subject trackers, monitoring schedules)
- Support audit and inspection readiness activities
- Vendor & Site Support
- Support vendor coordination (labs, couriers, central services)
- Help sites with document submissions, training materials, and study-related queries.
- Vendor & Site Support
- Support vendor coordination (labs, couriers, central services)
- Help sites with document submissions, training materials, and study-related queries
- Quality & Audit Readiness
- Assist with internal and external audits (if applicable)
- Ensure documents are audit-ready and up-to-date
- Track and support corrective and preventive actions (CAPA) when required
- General Administrative Tasks
- Manage study-related correspondence and filing
- Support project managers with operational activities as needed RELATED EXPERIENCE REQUIREMENT
- Relevant experience of 1-2 years in the field of Clinical Research
- Thorough knowledge of New Drugs and Clinical Trial Rules, 2019, GCP guidelines, ICMR guidelines 2017 and Drugs and Cosmetic Act regulations pertaining to clinical trials
- Strong academic record with strength in research with knowledge of research methodologies
- Experience of working in matrix business environments preferred
- Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards.
- Integrity driven decision making skills
- Sound functional knowledge in clinical research and operations
- Collaboration and teaming with ability to work in a matrix environment
- Sound analytical skills , Attention to detail ,Sense of urgency & desire to excel
- Intellectual curiosity , Result oriented and performance driven, Sound interpersonal & communication skills to effectively interact with a broad range of audience.