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Clinical Document Specialist at Novotech Global
Bangalore, karnataka, India -
Full Time

Start Date

Immediate

Expiry Date

29 Jun, 26

Salary

0.0

Posted On

31 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Trial Master File, Document Management, TMF Activities, eTMF Systems, ICH GCP Guidelines, Regulatory Requirements, SOP Adherence

Industry

Biotechnology Research

Description
The Clinical Document Specialist (CDS) will provide support for Trial Master File (TMF) activities to the clinical teams for assigned projects. This role will be responsible for the overall management and quality maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the Trial Master File (TMF) The CDS will have a strong focus on ensuring routine document management operations are performed with adherence to Novotech SOPs. This role to manage Trial Master Files (TMF), both electronic and paper in format according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs
Responsibilities
The Clinical Document Specialist will support clinical teams by managing and ensuring the quality maintenance of essential clinical trial documents, primarily focusing on the setup and upkeep of the Trial Master File (TMF). This role involves managing both electronic and paper TMFs in adherence to project requirements, ICH GCP guidelines, and relevant SOPs.