Novotech Hiring Document Management Associate in Bangalore

Novotech Document Management Associate Recruitment Bangalore

Novotech, a leading Asia-Pacific biotech specialist CRO, is seeking skilled professionals to fill 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 clinical research experience and a pharmaceutical or healthcare industry background, 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, including SharePoint and paper and electronic TMFs, to ensure all study documents are filed appropriately throughout the entire study. All documents must be scanned, uploaded, tracked, and filed according to Novotech’s (or Clients’) SOPs.
• DMA will review each document as received for quality to ensure it meets Novotech’s document requirements and will work with the project team to ensure high-quality study documents.
• DMA will provide reports on study document quality and team collection practices and provide updates to the study team to ensure all documents are collected promptly.
• Ensure the TMF is always ‘inspection ready’ and trial master file documents are filed contemporaneously and promptly by 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 the accuracy of the files by performing file reviews.
• Prepares the TMF for delivery at study closeout.

Qualifications

Candidates must possess at least 12 months of experience in a clinical research organization or equivalent. Practical experience 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.