Company: Sun Pharma Laboratories Ltd
Location: Mumbai, India (On-site – Corporate Office)
Department: Medical Affairs & Clinical Research
Job Type: Full-Time
Experience Required: 0–2 years (Freshers with strong clinical research training may be considered)
About the Company
Sun Pharma Laboratories Ltd is one of the largest pharmaceutical companies globally, known for its strong presence in specialty generics and innovative healthcare solutions. The organization fosters a performance-driven and growth-oriented work culture, empowering professionals to build impactful careers in clinical research and drug development.
Job Overview
The Clinical Trial Assistant (CTA) plays a critical role in supporting clinical trial operations, documentation, and coordination activities. This position is ideal for candidates looking to build a strong foundation in clinical research, regulatory compliance, and study management within a structured pharmaceutical environment.
Key Responsibilities
Administrative and Documentation Support
Maintain and update Trial Master File (TMF) and Investigator Site File (ISF)
Ensure all essential documents comply with ICH-GCP and regulatory requirements
Manage document tracking, version control, and approvals
Maintain study-related trackers and documentation logs
Study Coordination
Support planning, initiation, execution, and closure of clinical trials
Assist Clinical Research Associates (CRAs) with site management activities
Track study progress including patient enrolment, visit schedules, and monitoring reports
Manage invoice tracking and payment coordination for sites and vendors
Handle vendor code generation and tracking
Communication and Liaison
Act as a central communication point between sites, CRAs, project teams, and vendors
Coordinate meetings, training sessions, and teleconferences
Prepare meeting agendas, minutes, and follow-up actions
Regulatory and Compliance Support
Assist in ethics committee and regulatory submissions
Ensure adherence to SOPs, protocols, and regulatory guidelines
Track regulatory approvals, renewals, and expirations
Data and System Management
Enter and update clinical trial data in study management systems
Perform quality checks on documentation and data entries
Support query resolution with sites and data management teams
Logistics and Study Supplies Management
Track study materials including lab kits, documents, and investigational product shipments
Coordinate distribution of trial supplies to study sites
Study Documentation and Reporting
Prepare study reports, trackers, and dashboards
Maintain screening logs, subject trackers, and monitoring schedules
Support audit and inspection readiness
Vendor and Site Support
Coordinate with vendors such as laboratories, couriers, and central service providers
Assist sites with documentation, training materials, and study-related queries
Quality and Audit Readiness
Support internal and external audits
Ensure documentation is audit-ready and compliant
Assist in tracking and implementing CAPA activities
General Administrative Support
Manage study correspondence and filing systems
Assist project managers with operational and coordination tasks
Educational Qualification
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related healthcare disciplines
Postgraduate Diploma in Clinical Research is an added advantage
Experience Requirements
0–2 years of experience in Clinical Research, Clinical Trial Coordination, or hospital-based research roles
Freshers with strong academic background and clinical research training certifications may be considered
Required Skills and Competencies
Strong understanding of ICH-GCP, New Drugs and Clinical Trial Rules (2019), ICMR Guidelines (2017), and regulatory frameworks
Good knowledge of clinical trial processes and research methodologies
Strong analytical skills with attention to detail
Effective communication and stakeholder coordination abilities
Ability to work in a matrix and cross-functional environment
High level of integrity, accountability, and result orientation
Work Environment
Office-based role at corporate location in Mumbai
Collaborative and structured clinical research environment
Why Apply for This Role
Entry-to-mid level opportunity in a leading global pharmaceutical company
Strong exposure to end-to-end clinical trial operations
Career growth in Clinical Research, Medical Affairs, and Drug Development
Opportunity to work with experienced clinical research professionals
Important Note for Applicants
Candidates aiming to enter the clinical research domain can use this role as a stepping stone toward advanced roles such as Clinical Research Associate (CRA), Clinical Project Coordinator, or Clinical Data Manager.
How to Apply
Apply through the official careers page of Sun Pharma Laboratories Ltd or explore verified clinical research opportunities on ThePharmaDaily.com for global job openings.
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