Job title
:
Clinical Project Assistant
- Hiring Manager: Team Lead- Registry Site Operations
- Location: Hyderabad
- % of travel expected: Travel required as per business need
- Job type: Permanent and Full time
About The Job
Our Team:
Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D;, Data & Digital functions . Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool.
Main Responsibilities
The Clinical Project Assistant (CPA) will support for the below:
- Provide support to the Registries team for the set up and administration of electronic Trial Master File (eTMF)
ensuring adherence to protocol, Good Clinical Practices (GCP) guidelines and company Corporate and Local Standard Operating Procedures (SOPs).
- Responsible for TMF archiving process -Preparation of archiving, collection, reconciliation and filing of relevant documents.
- Manage the upload of documents for all existing and recent sites and ensure a primary Quality control (QC).
- Provide administrative support with project management activities.
- Coordinate the project schedule and ensure timely updates of key milestones and partner with Registries team.
- Develop and maintain relevant sections of various Registry materials.
- Support project budgetary tracking and or site payments as needed.
- Prepare correspondence, including meeting minutes, for the project team and/or customer.
- Manage and coordinate core file reviews and support audits as needed.
- Manage project specific e-Training tracking and overs