Syngene Clinical Research Associate Job For Life Sciences, Apply Online
Title: Sr. Clinical Research Associate
Date: 4 Jan 2025
Job Location: Bangalore
Department: Clinical Operations
About Syngene
Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries around the world. Syngene’s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by the passion of its 4240-strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation.
Job Description:
Role: Senior Clinical Research Associate
Key Responsibilities:
- Perform site selection, initiation, monitoring, and close-out visits in accordance with contracted scope of work, Standard Operating Procedures, and all applicable Good Clinical Practice (GCP) Guidelines and Regulations.
- Responsible for site management for the assigned protocols, sites, and therapeutic areas.
- Complete appropriate Standard Operating Procedure training, therapeutic area training, protocol training, and any relevant training required to perform job duties.
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and activities.
- Ensure the quality and integrity of study conducted at the site level in accordance with protocol and applicable regulations. Investigate and discuss quality issues with the Clinical Project Manager for resolution and implementation of Corrective Action and Preventive Action.
- Manage the progress and performance of the assigned study sites by following activities but not limited to: tracking regulatory and Ethics Committee submissions and approvals, subject recruitment, case report form (CRF) completion and submission, and data query generation and resolution.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation.
- Provide assistance to the Clinical Project Manager with the design of study tools, documents, and processes.
- Timely submission of timesheets for project-specific and other tasks.
Assignment as a Lead Clinical Research Associate (if required):
- Supporting the Clinical Project Manager for coordination within the project team.
- Delegation of project-level Clinical Project Manager responsibilities.
- The above responsibilities would be assigned by the reporting manager, and project-level task allocation would be performed.
Educational Qualification: M.Sc/M.Pharm/Pharm D, BAMS, BDS, MDS & BHMS/Any life science
Experience: 3 – 9 Years
Behavioural Skills:
- Should have good communication skills and should be a good team player.
- Ability to work successfully in a dynamic, ambiguous environment.
- Ability to meet tight deadlines and prioritize workloads.
- Ability to develop new ideas and creative solutions.
- Should be a focused employee.
Link to apply: APPLY ONLINE HERE
Keywords: Senior Clinical Research Associate, Bangalore job opening, Syngene Careers. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
