Job title: R&D eTMF Document Specialist

Location: Hyderabad
 

About the job

The eTMF Specialist plays a crucial role in managing the Trial Master File (TMF) documentation system, ensuring compliance with regulatory requirements and internal processes throughout the lifecycle of clinical studies. This position is responsible for maintaining the integrity and quality of clinical trial documentation, supporting study teams, and facilitating regulatory inspections.

As the central point of TMF oversight, the eTMF Specialist performs documentation activities across all levels within a study (study, country and site), maintaining a comprehensive view of TMF completeness and quality. They collaborate closely with the TMF manager, Clinical Operations Study Leaders (COSLs), Global Study Leaders (GSLs), the Clinical Operations Study Country Leader (COSCL) Site Monitor (SM) and other study team members to ensure proper documentation practices are followed.

The eTMF Specialist executes tasks with integrity, ensuring all activities are suitable for regulatory review. They work alongside various stakeholders, including the TMF management team, clinical study teams, CROs, and investigational sites.

Main responsibilities include:

• TMF Document Management

• Manage TMF documents in accordance with internal processes and applicable regulations

• Filing of documents regardless of language in eTMF

• Complete Metadata completion and quality control

• Creation, coordination and FU of User task management

• File review and Expected Document List (EDL) checks in coordination with TMF manager

• Check consistency between documents Initiate regular file checks ,FU on actions ,Communicate findings with study teams for action 

• Ensure completeness of study file at all times ,Share EDLs with TMF manager, COSL and COSCL.,FU with study teams in case of issues

• Perform independent quality control of documents submitted to the TMF, Review and verify proper indexing of documents in the eTMF system.

• Coordinate error corrections and manage query responses. Alert appropriate stakeholders and TMF manager of recurring issues or specific concerns

• Support TMF Contributors on processes and system usage. Support audit and inspection preparation activities.

• Contribute to document retrieval during regulatory inspections. Participate in process improvement initiatives.

• Support eTMF system evolution and testing. Track and report on TMF metrics and quality indicators.

• Liaise with TMF managers, clinical study teams, and vendors on TMF-related matters.

• Contribute to the development of TMF-related training materials and SOPs.

About you

• Bachelor's degree in Life Sciences, Pharmacy, or related field

• Experience in eTMF management or clinical documentation is a plus Knowledge of ICH-GCP, regulatory requirements, and clinical development process

• Experience with electronic TMF systems (Veeva Vault experience preferred) is a plus Strong attention to detail and organizational skills

• Excellent written and verbal communication skills in English Ability to work independently and as part of a team

• Problem-solving and analytical skills Customer service orientation Adaptability to new technologies and processes

• Ability to prioritize tasks and meet deadlines in a fast-paced environment

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!