Founded in 1993, Syngene International Ltd. offers integrated scientific services across pharmaceuticals, biotechnology, nutrition, animal health, and specialty chemical industries. Collaborating with industry leaders like Bristol-Myers Squibb, Baxter, Amgen, GSK, and Merck, Syngene helps accelerate R&D productivity and lower the cost of innovation. With over 4,240 scientists, Syngene delivers solutions for clients globally.
Job Description
Role: Senior Clinical Research Associate
Key Responsibilities
- Site Management and Monitoring:
- Conduct site selection, initiation, monitoring, and close-out visits following protocols, SOPs, GCP, and regulatory guidelines.
- Protocol Training and Communication:
- Administer protocol and study-related training to site staff and ensure clear communication of project expectations.
- Compliance and Quality Assurance:
- Ensure the quality and integrity of the study at the site level and resolve issues with the Clinical Project Manager (CPM).
- Performance Tracking:
- Monitor site progress, including subject recruitment, Ethics Committee submissions, CRF completion, and data query resolution.
- Documentation and Reporting:
- Create and maintain detailed visit reports and follow-up letters documenting site activities and findings.
- Support for Project Management:
- Assist the CPM in designing study tools, documents, and processes.
- Project Leadership:
- Act as a Lead Clinical Research Associate when required, coordinating tasks with the CPM and delegating responsibilities.
- Timesheet Management:
- Timely submission of timesheets for assigned projects and other tasks.
Educational Qualifications
- M.Sc., M.Pharm, Pharm D
- BAMS, BDS, MDS, BHMS
- Any relevant life sciences degree
Experience Required
- 3 to 9 years of relevant experience.
Behavioral Skills
- Strong communication and teamwork skills.
- Ability to thrive in dynamic environments and manage tight deadlines.
- Creative problem-solving and innovative thinking.
- Focused and organized work ethic.
