Sun Pharma Hiring Clinical Trial Assistant
Are you looking for a promising Clinical Trial Assistant role in India’s leading pharmaceutical company? This opportunity at Sun Pharma Careers is ideal for candidates aiming to build a successful Clinical Research Job profile. With hands-on exposure to clinical trials, documentation, and regulatory compliance, this role offers an excellent opportunity for life science graduates to enter the fast-growing clinical research industry.
About the Company
Sun Pharma Laboratories Ltd provides a dynamic and growth-driven environment where employees are encouraged to take ownership of their careers, continuously improve, and collaborate effectively. Guided by its philosophy of “Create Your Own Sunshine,” the organization promotes learning, leadership, and teamwork.
Job Details:
- Job Title: Clinical Trial Assistant
- Location: Mumbai
- Company: Sun Pharma Laboratories Ltd
- Office: Sun House – Corporate Office
Role Overview
The Clinical Trial Assistant (CTA) supports the clinical operations team in the planning, execution, and management of clinical studies. This role involves administrative coordination, documentation management, regulatory support, and collaboration with internal teams, sites, and vendors to ensure clinical trials are conducted efficiently and in compliance with applicable regulations and guidelines.
Key Responsibilities
- Administrative & Documentation Support
- Maintain and organize Trial Master File (TMF) and Investigator Site File (ISF)
- Ensure all essential documents comply with ICH-GCP, regulatory, and sponsor requirements
- Track, manage, and update study documents, versions, approvals, and trackers
- Study Coordination
- Assist in planning, initiation, execution, and closure of clinical studies
- Support Clinical Research Associates (CRAs) with site management activities
- Track enrolment status, visit schedules, and monitoring reports
- Assist in invoice tracking, payments, and vendor code generation
- Communication & Liaison
- Act as a communication bridge between sites, CRAs, project managers, and vendors
- Coordinate meetings, teleconferences, and training sessions
- Prepare and distribute agendas, minutes, and follow-up actions
- Regulatory & Compliance Support
- Assist with ethics committee and regulatory submissions
- Ensure compliance with SOPs, protocols, and regulatory guidelines
- Track regulatory documents, approvals, and expirations at site level
- Data & System Management
- Enter and update trial data in study management systems and trackers
- Perform quality control (QC) checks on documents and data
- Support query resolution with sites and data management teams
- Logistics & Study Supplies
- Track and manage study materials such as documents, lab kits, and IP shipment records
- Coordinate distribution of trial supplies to study sites
- Study Documentation & Reporting
- Assist in preparing reports, trackers, logs, and study summaries
- Maintain dashboards including screening logs, subject trackers, and monitoring schedules
- Support audit and inspection readiness
- Vendor & Site Support
- Coordinate with vendors (labs, couriers, central services)
- Support sites with documentation, training materials, and study-related queries
- Quality & Audit Readiness
- Assist with internal and external audits
- Ensure documentation is accurate, complete, and audit-ready
- Support corrective and preventive actions (CAPA) tracking
- General Administrative Support
- Manage study-related correspondence and filing
- Provide operational support to project managers as required
Candidate Profile
The ideal candidate is detail-oriented, organized, and proactive, with strong coordination and communication skills. They should be capable of working in a matrix environment while maintaining high standards of compliance and documentation accuracy.
Educational Qualification
- Bachelor’s or Master’s degree in Science, Clinical Research, or Life Sciences (e.g., Biology)
- Postgraduate Diploma in Clinical Research (preferred)
Experience
- 1–2 years of experience in Clinical Research or as a Clinical Research Coordinator (hospital setting preferred)
Additional Requirements & Competencies
- Strong knowledge of New Drugs and Clinical Trial Rules (2019), GCP, ICMR Guidelines (2017), and Drugs & Cosmetics Act
- Sound understanding of clinical research operations and methodologies
- Strong analytical skills and attention to detail
- Ability to work collaboratively in a matrix environment
- Effective communication and interpersonal skills
- High level of integrity, accountability, and result orientation
- Demonstrated performance through professional achievements or evaluations
Working Conditions
This is an office-based role.
