Job title: Project Specialist – Clinical Documentation Coordinator (CDC)
Job description: Mission statements 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 Sa
Mission statements 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. EducationalQualifications/Experience 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 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) At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
Location: Hyderabad, Telangana – Secunderabad, Telangana
Job date: Wed, 16 Mar 2022 23:41:23 GMT
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