Job Title

Clinical Trial Assistant

Business Unit

Medical Affairs & Clinical Research

Location:

Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Your Tasks And Responsibilities

Administrative & Documentation Support
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.

COMPETENCY REQUIREMENT

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.

Job Requirements

PHYSICAL REQUIREMENTS/WORKING CONDITIONS The role is office based.

Educational Qualification

Minimum qualification requirement is to have Bachelor's or Master's degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate Diploma in Clinical Research

Experience

1-2 years in Clinical Research/Clinical Research Coordinator (Hospitals)

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

SUN PHARMA

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Clinical Trial Assistant