TMF Specialist

    • Bangalore, India

Site Name: India - Karnataka - Bangalore
Posted Date: Jan 13 2020
Minimum Experience:
Clinical Document management exposure a definite requirement
Scientific background and knowledge of clinical trials (including ICH-GCP) is an asset
Microsoft office (Excel, PowerPoint, Word, Outlook, MS Project)
Advanced Excel, MS project, eTrack, Documentum and SAP are an asset
Time management skills, ability to clearly identify priorities and manage multiple tasks
Good understanding of the principles of project planning & project management.

Key Responsibilities:

  • Provide operational and administrative support for the study TMF management.
  • Ensure high quality and up-to-date TMF management in clinical study teams. The role is embedded into several study teams.
  • Own and maintain the study TMF management plan and ensures adherence by the study team members
  • Supports the SDL in planning and executing TMF management related activities of the clinical trial teal in order to ensure that the TMF is in good shape ad updated on a timely manner.
  • Responsible to track eTMF periodic reviews for studies and provides regulars updates to the SDL/ Head TMF Operations
  • Primary point of contact for study team members for any TMF-related question
  • Support document owners to ensure TMF compliance.
  • In charge of the set-up of the TMF for each new study (on-boarding of study contributors, TMF plan, performing preparation of the documents in the system)
  • In charge, during the maintenance of the TMF that the contributors are providing their documentation in an in-stream basis (by running KPI, by running reports, by running QC checks if needed).
  • Take the appropriate relevant actions to address gaps, issues and risks
  • Provide training to newcomers and refresher training to existing users.
  • Act in a network across study and project assignments to make best use of location and time-zone
  • Collect study wet-ink paper documents, prepares the wet-ink documents for archiving, arrange shipments of those to the clinical archive team for long term retention
  • May lead inspection/audit preparation related activities with regards to study-related documentation for studies in their Region providing documentation in timely manner and assisting with CAPAs as related to TMF finding in the region.


Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview. Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way.

GlaxoSmithKline does not charge any fee whatsoever for recruitment process. Please do not make payments to any individuals / entities in connection with recruitment with any GlaxoSmithKilne (or GSK) group company at any worldwide location. Even if they claim that the money is refundable.
If you come across unsolicited email from email addresses not ending in gsk.com or job advertisements which state that you should contact an email address that does not end in "gsk.com", you should disregard the same and inform us by emailing askus@gsk.com, so that we can confirm to you if the job is genuine.

GSK is a uniquely science-led global healthcare organization on a mission to help people do more, feel better, and ultimately live longer.

GSK Company Image


Back to top