Syngene International Ltd. is hiring CTA – Clinical Operations (CTA-ClinOps) professionals to support clinical trial management activities in Bangalore. This opportunity is ideal for candidates with a background in Clinical Research, Life Sciences, Pharmacy, or Medical Sciences who want to build a career in clinical trial coordination and clinical operations.
The role focuses on supporting Clinical Study Managers (CSM), Clinical Research Associates (CRAs), and clinical teams by maintaining trial documentation, managing Trial Master Files (TMF), coordinating study communications, and ensuring compliance with ICH-GCP guidelines and regulatory requirements.
Syngene is a globally recognized contract research, development, and manufacturing organization (CRDMO) providing integrated scientific services from early discovery to commercial supply. The company places strong emphasis on quality, safety, and regulatory compliance across all clinical research operations.
Job Overview
Role: CTA – Clinical Operations (CTA-ClinOps)
Company: Syngene International Ltd.
Department: Clinical Operations – T&CR
Location: Bangalore, India
Employment Type: Full-time
This Clinical Trial Assistant (CTA) role involves supporting clinical study activities including document management, trial coordination, regulatory submissions, and communication with clinical sites and vendors.
Key Responsibilities
1. Clinical Trial Documentation & TMF Management
- Maintain and update Trial Master File (TMF) and Investigator Site Files (ISF)
- Ensure accurate filing and archiving of clinical documents
- Conduct quality checks for document completeness and compliance
2. Regulatory & Ethics Committee Support
- Assist in preparing regulatory and ethics committee submissions
- Track regulatory approvals and study start-up milestones
- Maintain documentation records for audits and inspections
3. Clinical Trial Coordination
- Support Clinical Study Managers (CSM) and Clinical Research Associates (CRAs) in tracking study activities
- Coordinate investigator meetings, site initiation visits, monitoring visits, and close-out visits
4. Clinical Data & Study Tracking
- Manage Case Report Forms (CRFs) and clinical data flow
- Enter and track data in Clinical Trial Management Systems (CTMS)
- Maintain study logs including enrollment logs and site contact lists
5. Communication & Stakeholder Coordination
- Act as a central communication point between clinical teams, sites, and vendors
- Distribute study communications and updates
- Coordinate document translation with external agencies
6. Trial Supply Management
- Assist with clinical trial supply shipment coordination
- Track inventory and reconcile supplies with site reports
7. Audit & Inspection Support
- Prepare documentation for internal or regulatory audits
- Support resolution of audit findings and follow-up actions
8. Compliance & Training
- Ensure adherence to ICH-GCP guidelines, SOPs, and regulatory requirements
- Maintain training records for sponsor and site personnel
Eligibility Criteria
Candidates applying for this Clinical Trial Assistant job in Bangalore should have the following qualifications:
Education
- M.Sc (Life Sciences)
- M.Pharm
- Pharm.D
- BAMS / BHMS / BDS / MDS
- Any Life Science degree
Preferred Experience
- Experience as Clinical Research Coordinator (CRC) or in clinical trial operations
- Understanding of GCP guidelines and clinical documentation
Skills Required
- Strong clinical documentation management skills
- Knowledge of clinical trial processes and CTMS systems
- Excellent communication and coordination abilities
- Ability to manage multiple tasks and meet deadlines
- Strong attention to detail and regulatory compliance awareness
Why Join Syngene?
Working with Syngene offers opportunities to build a career in global clinical research and drug development.
Key benefits include:
- Exposure to global clinical trials and CRO operations
- Work with experienced clinical research professionals
- Opportunities for career growth in clinical operations
- Collaborative work culture focused on innovation and safety
How to Apply
