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Senior Document Management Associate 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

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Document Management, Trial Master File, TMF, eTMF, QC Reviews, ICH GCP Guidelines, Regulatory Requirements, Clinical Teams, SOPs

Industry

Biotechnology Research

Description

The Senior Document Management Associate (SDMA) will provide support for Trial Master File (TMF) activities to the clinical teams for all assigned projects. This role will be responsible for working with study teams, both internal and external, to manage both paper and electronic Trial Master Files (TMF), according to project requirements, ICH GCP guidelines, local/global regulatory requirements and Novotech/Client SOPs. The SDMA will also be responsible for performing comprehensive QC reviews.

Responsibilities

The Senior Document Management Associate will support Trial Master File (TMF) activities for clinical teams across assigned projects, managing both paper and electronic TMFs according to regulatory and procedural guidelines. This role also includes the responsibility of performing comprehensive Quality Control (QC) reviews.