Clinical Trial Assistant Clinical Operations Job at Syngenein Bangalore. Clinical research coordination, TMF management, regulatory documentation career opportunity for life sciences.
Company Overview
Syngene International Limited is a globally recognized contract research, development, and manufacturing organization (CRDMO) that provides integrated scientific services to pharmaceutical, biotechnology, and healthcare companies. Headquartered in India, the company supports drug discovery, development, and manufacturing processes from early research stages to commercial production.
Syngene collaborates with leading global pharmaceutical companies and research organizations to accelerate innovation in drug development. The company emphasizes scientific excellence, operational quality, and strict adherence to safety and compliance standards across all its facilities.
Professionals joining Syngene gain exposure to advanced clinical research programs, global study operations, and collaborative projects across multidisciplinary healthcare teams. Clinical Trial Assistant Clinical Operations Job at Syngene
Job Location & Employment Type
- Company: Syngene International Limited
- Job Location: Bangalore, Karnataka, India
- Employment Type: Full-Time
- Department: Clinical Operations – T&CR Division
- Industry: Clinical Research / Life Sciences
This role supports clinical trial operations and documentation processes for ongoing clinical studies managed by the clinical operations team. Clinical Trial Assistant Clinical Operations Job at Syngene
Open Position / Department Details
Clinical Trial Assistant – Clinical Operations (CTA-ClinOps)
Syngene is looking for motivated professionals to support clinical trial activities and documentation management within the Clinical Operations department.
The selected candidate will work closely with Clinical Study Managers (CSM), Clinical Research Associates (CRAs), and cross-functional clinical teams to maintain study documentation, coordinate trial-related activities, and ensure regulatory compliance.
This role is particularly suitable for candidates with prior experience in clinical trial coordination, clinical research sites, or clinical operations support roles. Clinical Trial Assistant Clinical Operations Job at Syngene
Key Roles & Responsibilities
The Clinical Trial Assistant will support clinical study execution by managing documentation, coordinating communication, and ensuring compliance with regulatory and operational standards. Clinical Trial Assistant Clinical Operations Job at Syngene
Clinical Study Support
- Assist Clinical Study Managers and Clinical Research Associates in maintaining clinical trial systems used to track site compliance and study performance.
- Support study teams in managing clinical documentation and reports according to project requirements.
- Help coordinate various clinical trial activities within established timelines.
Clinical Documentation Management
- Prepare, distribute, file, and archive clinical study documents following standard operating procedures.
- Ensure study documentation remains complete, accurate, and inspection-ready.
- Support periodic review of study files to maintain documentation quality.
Trial Master File (TMF) Management
- Maintain and update Trial Master Files (TMF) and Investigator Site Files (ISF).
- Ensure proper organization, filing, and tracking of critical clinical documents.
- Perform document quality checks to confirm completeness and accuracy.
Regulatory Documentation Support
- Assist with preparation and submission of documents to regulatory authorities and ethics committees.
- Track regulatory approvals and study start-up milestones.
- Maintain records related to regulatory and ethics committee submissions.
Case Report Form (CRF) and Data Flow Management
- Assist in tracking Case Report Forms (CRFs) and associated queries.
- Support monitoring of clinical data flow between sites and data management teams.
- Maintain accurate documentation related to clinical data activities.
Clinical Trial Coordination
- Support planning and tracking of clinical trial activities in coordination with CRAs and Clinical Study Managers.
- Assist with scheduling investigator meetings, site initiation visits, monitoring visits, and close-out visits.
- Provide administrative and operational support during study execution.
Communication and Liaison Activities
- Act as a central contact point for communication between clinical teams, research sites, and external vendors.
- Distribute study-related updates and communications to relevant stakeholders.
- Coordinate communication across internal departments involved in clinical trials.
Clinical Trial Management Systems (CTMS)
- Enter and track clinical trial information within Clinical Trial Management Systems.
- Maintain logs including site contact lists, enrollment tracking records, and document trackers.
- Generate study status reports and maintain accurate records of protocol deviations and study updates.
Clinical Supply Management
- Support shipment coordination of clinical trial supplies and investigational products to research sites.
- Maintain records related to supply shipments and inventory reconciliation.
- Assist with documentation associated with clinical supply management.
Audit and Inspection Support
- Prepare documentation for internal audits and regulatory inspections.
- Ensure documentation remains organized and readily accessible for audit purposes.
- Assist in responding to audit findings or follow-up actions.
Translation and Documentation Support
- Coordinate with translation agencies for translation and back-translation of study-related documents when required.
- Maintain documentation records for translated study materials.
Administrative Support
- Perform administrative tasks to assist clinical teams in executing study activities.
- Maintain accurate timesheets and records related to project work.
- Support leadership in generating study status reports and operational metrics.
Clinical Trial Assistant Clinical Operations Job at Syngene
Safety and Compliance Responsibilities
All employees at Syngene are expected to adhere to strict safety and compliance standards.
Key expectations include:
- Following all company safety guidelines and procedures.
- Promoting a strong Environment, Health, and Safety (EHS) culture.
- Ensuring compliance with company integrity and quality standards.
- Completing all mandatory training related to safety, health, and data integrity.
- Supporting safe workplace practices and operational discipline.
Eligibility Criteria
Education
Candidates must hold a degree in one of the following disciplines:
- M.Sc. in Life Sciences
- M.Pharm / Pharm.D
- BAMS
- BDS / MDS
- BHMS
- Any Life Sciences or healthcare-related qualification
Experience
- Candidates with experience as a Clinical Research Coordinator (CRC) are preferred.
- Relevant experience in clinical trial conduct or clinical operations support roles is advantageous.
- Experience working with clinical research documentation and trial coordination processes is beneficial.
Skills Required
Successful candidates should demonstrate the following skills:
Clinical Research Skills
- Understanding of clinical trial workflows and documentation requirements
- Knowledge of Trial Master File (TMF) management
- Familiarity with clinical study coordination processes
Communication and Collaboration
- Strong communication and interpersonal skills
- Ability to coordinate with cross-functional clinical teams
- Effective stakeholder communication and documentation skills
Organizational Skills
- Ability to manage multiple tasks and meet tight deadlines
- Strong attention to detail and document accuracy
- Efficient workload prioritization and time management
Problem Solving and Adaptability
- Ability to work effectively in dynamic work environments
- Capability to generate innovative ideas and solutions
- Strong focus on quality and operational efficiency
Clinical Trial Assistant Clinical Operations Job at Syngene
Salary & Benefits
Compensation for this role will be offered as per company norms and industry standards based on the candidate’s qualifications and experience. Clinical Trial Assistant Clinical Operations Job at Syngene
Employees may also receive benefits such as:
- Competitive salary structure
- Career growth opportunities within clinical research
- Exposure to global pharmaceutical research projects
- Professional learning and development opportunities
Selection Process
The recruitment process generally includes several stages:
- Resume screening and application review
- Initial HR discussion
- Technical or functional interview
- Final interview with hiring managers
- Offer and onboarding
The exact process may vary depending on hiring requirements. Clinical Trial Assistant Clinical Operations Job at Syngene
How to Apply
Interested candidates can apply online through the official careers portal of Syngene for the CTA-ClinOps (Clinical Trial Assistant – Clinical Operations) position.
Applicants should ensure their resume highlights clinical research experience, trial coordination activities, and knowledge of clinical documentation processes. Clinical Trial Assistant Clinical Operations Job at Syngene
Important Dates
- Application Deadline: Not specified
Early applications are recommended since clinical research positions may close once suitable candidates are identified.
Why Apply for This Pharma Job?
This position offers an excellent opportunity for professionals looking to build a career in clinical trial operations and clinical research coordination. Clinical Trial Assistant Clinical Operations Job at Syngene
Key benefits include:
- Opportunity to work with a leading global contract research organization
- Exposure to international clinical trials and regulatory processes
- Hands-on experience with trial documentation and study coordination
- Collaboration with experienced clinical research professionals
- Strong career growth potential in the clinical research industry
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that shares career opportunities within the pharmaceutical, biotechnology, and healthcare sectors.
We are not affiliated with Syngene International Limited or any company mentioned in this job post. Candidates should verify all job details and apply only through the official company website or authorized recruitment portals. Clinical Trial Assistant Clinical Operations Job at Syngene
Final Call-to-Action
Candidates with experience in clinical trial coordination or clinical research support roles are encouraged to apply and advance their careers in clinical operations. Clinical Trial Assistant Clinical Operations Job at Syngene
