Project Specialist – TMF documentation will work in close collaboration with the Trial Master File (TMF) management team
Essential Job duties and responsibilities
To manage TMF documents for the studies under the responsibility of Sanofi, Vaccines Business Unit, in accordance with internal processes and all applicable regulations.
To review the quality and the indexing of documents submitted to the TMF by the contributors during TMF Independent Quality Control (IQC) activities in accordance with internal processes and all applicable regulations
To coordinate the correction of errors discovered during the TMF IQC process and at the request of TMF Contributors
To alert the TMF Manager and/or TMF QC Operational Manager as appropriate of recurrent or specific issues which occur during a study or across studies
To support TMF Contributors on TMF management processes and the use of the Electronic Trial Master File (eTMF) system
Management of the Study TMF:
Project Specialist – TMF documentation QC’s TMF documents submitted by the Contributors in accordance with internal processes and applicable guidelines:
Perform an independent QC on TMF documents according on an ongoing basis, queries any documents that do not meet required quality criteria, coordinates the implementation of query responses, and manage any needed corrections in accordance with the processes documented in applicable guidelines.
Reports any recurrent or specific issues discovered when reviewing TMF documents to the TMF Manager assigned to the study and/or to the Operational Manager for the TMF Document QC team as appropriate
Provides support to TMF Contributors on Sanofi TMF processes as well as Sanofi eTMF processes and questions
Project Specialist – TMF documentation may perform some TMF Manager responsibilities as back-up if required
Collaborates effectively with TMF management team, and Clinical Study Team (Sanofi internal and external associates including MedHub and CRO).
Downloads the documents from Vault RIM and uploads to eTMF Vault Clinical and vice versa
Knowledge, Skills & Competencies / Language
Strong organizational and project management skills. Ability to review documents from multiple ongoing studies.
Propose technical solutions based on previous experience and expertise gained within the Project Specialist – TMF documentation role.
Stakeholder management
Project management
Publication submission
Qualifications
Graduate/Post-graduate degree in Pharmacy or life sciences
Experience in Clinical Research is desirable
Pharmaceutical industry experience should be within comparable sectors or roles (clinical documentation specialist/eTMF QC reviewer/Clinical Trial Assistant)
Experience with an Electronic Document Management system or Electronic Trial Master File system; exposure to Veeva Vault will be an added advantage
Any other requirements of the job
1-3 years of experience in eTMF coordination/management experience
Knowledge of the Clinical Development process
Knowledge of TMF regulations, ICH, GCP etc.
A technophile who is crazy about technology and passionate about blogging.
I care by sharing recent advancements in technology and try to reach out to the minds of people
