Clinical Document Specialistt (Novotech)

Roles and Responsibilities

Job Title: Pharmacovigilance Associate

Job Identification: 3829

Job Type: Full-Time

Location:

Ground Floor, Unit 1, Block E, Helios Business Park,
Bangalore – 560103

The Clinical Document Specialist (CDS) provides support for Trial Master File (TMF) activities to clinical teams across assigned projects. This role is responsible for the overall management and quality maintenance of essential clinical trial documents, including the setup and ongoing maintenance of the Trial Master File (TMF). The CDS ensures that all documentation is complete, accurate, and organized throughout the clinical study lifecycle.

Additionally, the role focuses on performing routine document management operations in strict adherence to company Standard Operating Procedures (SOPs). The CDS manages both electronic and paper-based TMFs in accordance with project requirements, while ensuring compliance with International Council for Harmonisation Good Clinical Practice (GCP), as well as local and global regulatory standards and client SOPs. Strong attention to detail and consistency in documentation practices are essential to maintain audit readiness and regulatory compliance.