Syngene International Ltd is hiring experienced professionals for the role of Senior Clinical Research Associate (Sr. CRA) in its Clinical Operations โ T&CR division. Candidates with qualifications in M.Pharm, PharmD, MSc, or other life sciences disciplines and relevant experience in clinical research are encouraged to apply.
This opportunity is ideal for professionals looking to grow their career in clinical trial monitoring, site management, and regulatory compliance within the CRO and clinical research industry.
Syngene is a globally recognized contract research, development, and manufacturing organization (CRDMO) known for providing integrated scientific services from early drug discovery to commercial manufacturing.
Job Overview
Job Title: Senior Clinical Research Associate
Company: Syngene International Ltd
Department: Clinical Operations โ T&CR
Location: Bangalore, India
Industry: Clinical Research / CRO / Pharma
Key Responsibilities
The Senior Clinical Research Associate will play a crucial role in ensuring the quality and integrity of clinical trials conducted at study sites.
Major responsibilities include:
Clinical Trial Monitoring
- Perform site selection, initiation, monitoring, and close-out visits according to SOPs and GCP guidelines.
- Ensure protocol compliance and regulatory adherence across assigned clinical trial sites.
Site Management
- Manage study sites, therapeutic areas, and assigned protocols.
- Maintain strong communication with clinical trial sites and investigators.
Study Documentation
- Prepare and maintain trial master files and monitoring documentation.
- Submit monitoring visit reports, follow-up letters, and action plans.
Regulatory Compliance
- Track Ethics Committee submissions and approvals.
- Ensure Case Report Form (CRF) completion and data query resolution.
Quality Assurance
- Identify quality issues and coordinate Corrective and Preventive Actions (CAPA) with the Clinical Project Manager.
- Ensure clinical trials meet ICH-GCP and regulatory standards.
Training & Communication
- Conduct protocol and study training for site teams.
- Maintain continuous communication with stakeholders throughout the trial lifecycle.
Required Qualifications
Candidates must meet the following educational requirements:
- M.Sc (Life Sciences)
- M.Pharm
- PharmD
- BAMS
- BDS / MDS
- BHMS
- Any other relevant Life Sciences degree
Required Skills
Successful candidates should possess:
- Strong clinical research and trial monitoring expertise
- Knowledge of GCP guidelines and regulatory requirements
- Excellent communication and teamwork skills
- Ability to work in fast-paced clinical operations environments
- Strong documentation and reporting capabilities
- Ability to meet tight deadlines and manage multiple projects
Experience Required
Syngene is looking for candidates with experience working as a Senior Clinical Research Associate (Sr. CRA) in clinical trials or clinical operations.
Professionals with experience in:
- Clinical monitoring
- Site management
- Clinical documentation
- Regulatory compliance
will be preferred.
Workplace Safety & Compliance
Syngene maintains a strong Environment, Health, and Safety (EHS) culture. Employees are expected to:
- Follow company safety protocols and SOPs
- Maintain data integrity and quality standards
- Participate in mandatory safety and compliance training
Why Work at Syngene?
Working at Syngene offers multiple career advantages including:
- Exposure to global clinical trials
- Opportunities in clinical operations and CRO industry
- Competitive salary packages
- Strong learning and career growth environment
- Commitment to workplace safety and regulatory compliance
Salary (Estimated)
โน12 LPA โ โน22 LPA (Approx. Industry range for Senior CRA roles in India)
How to Apply
