21 Sep
|
Clario
|
Bengaluru
Join Clario, a part of Thermo Fisher Scientific and help ensure the secure, accurate, and timely delivery of critical clinical trial documentation that supports global research programs. As an Archive Specialist within our Digital Physiology Data Management team, you will play a vital role in managing final study archives following database lock, ensuring study documentation is complete, organized, and compliant with customer and regulatory requirements. Working across multiple studies and collaborating with project teams throughout the organization, you will help drive operational excellence while supporting efficient study closeout activities and delivering an exceptional customer experience.
What We Offer
- Competitive pay and incentives.
- Provident fund and medical insurance.
- Engaging employee programs and local events.
- Modern office spaces and work from home flexibility.
What You'll Be Doing
- Serve as the primary owner of post-database lock final archive deliverables for multiple studies simultaneously.
- Identify, collect, verify, audit,
and organize clinical trial documentation required for sponsor and site archives.
- Conduct initial archive audits and assess documentation completeness following formal archive requests.
- Create and maintain study-specific archive documentation and provide standard archive templates to project teams.
- Build and manage complex archive directory structures for both site and sponsor archive packages.
- Coordinate document acquisition activities and work closely with study teams to obtain outstanding closeout documentation.
- Support data generation activities, including study design acquisition, environment setup, reporting activities, and documentation review.
- Perform post-data generation processing activities and ensure archive contents meet quality and compliance requirements.
- Execute quality reviews of archive packages and associated documentation prior to final delivery.
- Prepare, package, upload, and coordinate
📌 Archive Specialist, Data Management (Bengaluru)
🏢 Clario
📍 Bengaluru