Sanofi Life Sciences Project Specialist Documentation Recruitment
Sanofi Life Sciences Project Specialist Documentation Recruitment, Apply Online. Interested and eligible applicants can check out all of the details on the same below:
Job Title – Project Specialist – TMF documentation
Job ID – R2636806
Location – Hyderabad
Mission statements –
The clinical Documentation Coordinator (CDC) will work in close collaboration with the Trial Master File (TMF) management team.
Major responsibilities include –
- 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.
Educational Qualifications/Experience –
- Graduate/Post-graduate degree in 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
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.
Job Specific Competencies –
- Rigour, Organization skills
- Computer skills (Electronic Trial Master File System, Microsoft Office, especially Excel,
- Effective communication
- Ability to work in a team
- Excellent level of English (written and spoken)
APPLY ONLINE
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