Trial Master File (TMF) Lead
This role involves leading the setup, maintenance, and archival of Trial Master Files (TMF) for clinical studies at Dr. Reddy's Laboratories. The successful candidate will act as the primary point of contact for TMF activities, ensuring quality, completeness, and compliance with regulatory standards. Responsibilities include overseeing document flow, managing cross-functional relationships, and supporting internal or external audit processes. The position requires a post-graduate degree in a relevant medical or scientific field.
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Experience
Experience not specified
Function
Operations
Work mode
Onsite, India
Company
Tier 2
What you will work on
This role involves leading the setup, maintenance, and archival of Trial Master Files (TMF) for clinical studies at Dr. Reddy's Laboratories. The successful candidate will act as the primary point of contact for TMF activities, ensuring quality, completeness, and compliance with regulatory standards. Responsibilities include overseeing document flow, managing cross-functional relationships, and supporting internal or external audit processes. The position requires a post-graduate degree in a relevant medical or scientific field.
TAL's take
Stable role at a well-regarded global pharmaceutical company, though technical requirements are specialized rather than broad engineering.
The JD provides a highly specific set of responsibilities centered on TMF management, clinical trial documentation, and audit readiness.
Must haves
- Lead TMF setup, maintenance, and close-out
- Experience with eTMF systems
- Knowledge of CDISC TMF reference model
- Experience with SOPs and clinical trial regulations
- Post Graduate in Science, Pharmacy, or Medical Degree
Tools and skills
About the company
Established global pharmaceutical company with significant operations but not a tier-1 pure-play technology firm.
Posts mentioning Dr. Reddy's Laboratories
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Video: https://youtu.be/II8Q1A5Xgrg TL;DR: There is only 2 motivations: Internal, External - it can't be both. External motivation are driven by fear, anxiety (environment). It only works when you are under stress (eg. have to complete this assignment) and hence vanishes under lack of necessity. Internal Motivation are driven by curiosity and novelty. It is driven out of freedom, and not out of something-which-must-be-done. This type of Motivation is needed for things like self care (eg: go gym, sleep well) Try to throw away the outcomes and expectations - do things because you wish to, not forced to.
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