Novotech Document Management Associate Recruitment Bangalore

Novotech, a leading Asia-Pacific biotech specialist CRO, is seeking skilled professionals for the role of Document Management Associate in Bangalore. This position offers a unique opportunity to support clinical teams in managing Trial Master Files (TMF), both electronic and paper formats, according to project requirements and regulatory guidelines. If you have experience in clinical research and a background in the pharmaceutical or healthcare industry, this role is perfect for you.

About Novotech

Novotech is renowned for providing comprehensive clinical development services across all trial phases and therapeutic areas. With offices in 11 geographies and partnerships with key medical institutions, Novotech is committed to delivering high-quality, innovative solutions in the biotech sector.

Job Details

Position: Document Management Associate
Location: Bangalore
Experience: At least 12 months in a clinical research organization or equivalent

Responsibilities

As a Document Management Associate at Novotech, you will:

Will receive all study documentation for assigned projects; DMA will set up, receive, track and maintain electronic or paper TMFs according to the requirements of ICH GCP and Novotech (or client) SOPs.
DMA will use all required study systems to ensure all study documents are filed appropriately throughout the entire study; including SharePoint and paper and electronic TMFs; all documents are to be scanned, uploaded, tracked and filed according to Novotech (or Clients) SOPs.
DMA will review each document as received for quality to ensure the document meets Novotech essential document requirements; will work with the project team to ensure study documents are of high quality.
DMA will provide reports on study document quality and collection practices of the team and provide updates to the study team to ensure all documents are collected in a timely manner.
Ensure the TMF is always ‘inspection ready’ and trial master file documents are filed contemporaneously in a timely manner, in accordance with project timelines.
Adheres to TMF SOPs, KPIs and relevant TMF process-supporting guidance.
Performs interim eTMF exports/uploads for the sponsor or 3rd party, if applicable to the assigned project.
Runs monthly reports to ensure accuracy of the files by performing file reviews.
Prepares the TMF for delivery at study closeout.

Novotech Hiring Document Management Associate in Bangalore

Qualifications

Candidates must possess at least 12 months of experience in a clinical research organization or equivalent. Practical experience in handling Trial Master File activities, including electronic TMFs (eTMF), is essential. A background in the pharmaceutical, CRO, or healthcare industry is advantageous.

How to Apply

If you are ready to take on this exciting challenge, apply now! Visit the Novotech career page and submit your application for the Document Management Associate position in Bangalore.

Apply here: Novotech Career Page