Job Title: CTA – Clinical Operations (ClinOps)
Company: Syngene International Ltd.
Location: Bengaluru, Karnataka, India
Department: Clinical Operations – T&CR
Division: Discovery Services
Job Type: Full-Time
Experience Required: 1–3 Years
Education: M.Sc., M.Pharm, Pharm.D, BAMS, BDS, MDS, BHMS, or any Life Sciences degree
About Syngene
Syngene International Ltd. is an innovation-led contract research, development, and manufacturing organization (CRDMO) providing integrated scientific services from early discovery through commercial manufacturing. Headquartered in Bengaluru, India, Syngene collaborates with global pharmaceutical, biotechnology, and healthcare companies to accelerate drug discovery, clinical development, and commercialization.
The company maintains a strong commitment to safety, quality, and operational excellence, ensuring that all research and development activities comply with international regulatory standards and ethical practices.
Job Summary
Syngene is seeking a Clinical Trial Assistant (CTA) – Clinical Operations to support the execution and management of clinical trials within the Clinical Operations team. The role involves assisting Clinical Study Managers (CSM) and Clinical Research Associates (CRAs) in maintaining clinical systems, managing trial documentation, and coordinating operational activities to ensure studies are conducted efficiently and in compliance with regulatory guidelines.
The CTA will play a key role in managing trial documentation, maintaining the Trial Master File (TMF), coordinating communications between study teams and external stakeholders, and ensuring clinical trial documentation remains audit and inspection ready.
Key Responsibilities
Assist Clinical Study Managers and Clinical Research Associates in maintaining clinical trial management systems and updating study-related data to track site performance and compliance.
Support preparation, handling, distribution, filing, and archiving of clinical trial documentation and reports in accordance with project requirements and standard operating procedures.
Maintain and update Trial Master Files (TMF) and Investigator Site Files (ISF) to ensure regulatory compliance and audit readiness.
Perform quality checks on clinical trial documentation to ensure completeness, accuracy, and compliance with regulatory standards.
Assist with the preparation and submission of regulatory documents to ethics committees and regulatory authorities.
Track regulatory approvals and study start-up milestones for clinical studies.
Coordinate with Clinical Study Managers and CRAs to plan and track key clinical trial activities.
Assist in scheduling investigator meetings, site initiation visits, monitoring visits, and study close-out visits.
Serve as a communication liaison between internal clinical teams and external stakeholders including study sites and vendors.
Manage and track Case Report Forms (CRFs), queries, and clinical data flow within the clinical trial management systems.
Maintain study-related logs including site contact lists, screening and enrollment logs, and essential document trackers.
Support coordination of clinical trial supplies and investigational product shipments to study sites.
Track study supply inventory and reconcile documentation with site reports.
Coordinate with translation agencies for translation and back-translation of study documents where required.
Prepare documentation and provide support during internal audits and regulatory inspections.
Assist in responding to audit observations and implementing follow-up actions where required.
Maintain training records for study personnel and ensure compliance with Good Clinical Practice (GCP) and company SOPs.
Provide administrative support to clinical operations teams to ensure smooth execution of clinical trial activities.
Submit timesheets and maintain accurate documentation for project-related tasks.
Safety and Compliance Responsibilities
Ensure adherence to Syngene’s environmental, health, and safety (EHS) policies and operational procedures.
Promote safe work practices and support the development of systems that maintain safety and regulatory compliance.
Complete all mandatory training related to data integrity, safety procedures, and compliance standards.
Ensure all activities align with Syngene’s quality standards and corporate compliance policies.
Required Skills and Competencies
Strong understanding of clinical trial processes and Good Clinical Practice (GCP) guidelines.
Experience with clinical trial documentation management including TMF and ISF maintenance.
Familiarity with Clinical Trial Management Systems (CTMS) and clinical data tracking processes.
Excellent organizational and documentation management skills.
Strong verbal and written communication skills.
Ability to manage multiple tasks, prioritize workloads, and meet strict project timelines.
Strong teamwork and collaboration skills within cross-functional clinical research teams.
Ability to work effectively in dynamic and fast-paced clinical research environments.
Experience Required
Candidates should possess 1–3 years of experience in clinical research operations, preferably as a Clinical Trial Assistant (CTA), Clinical Research Coordinator (CRC), or similar role supporting clinical trial execution within pharmaceutical companies, biotechnology organizations, or contract research organizations (CROs).
Syngene Core Values
All employees at Syngene are expected to demonstrate alignment with the organization’s core values:
Excellence
Integrity
Professionalism
Equal Opportunity Statement
Syngene International Ltd. is an equal opportunity employer committed to providing fair employment opportunities to all individuals regardless of age, gender, race, disability, religion, nationality, or any other protected characteristic under applicable law. The company also provides reasonable accommodations for qualified individuals with disabilities during the recruitment process.
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