Support the setup, administration, and maintenance of electronic Trial Master File (eTMF), IMPACT CTMS/eSTRA, and related clinical tools.
Assist in project setup from initiation to closure, including site document collection, archiving, and quality control.
Maintain study portals, version-controlled documents, and e-training records.
Track project timelines and milestones, providing progress reports.
Draft, update, and maintain key study documentation, SOPs, manuals, and training guides.
Conduct file reviews and support internal/external audits to ensure document completeness and regulatory compliance.

Job Requirements

Bachelor's degree in Life Sciences, Pharmacy, or a related field.
Possess strong knowledge of ICH-GCP guidelines and clinical trial methodologies.
Demonstrate effective communication and relationship management skills with cross-functional teams.
Be proficient in Microsoft Office and comfortable with digital tools.
Exhibit high proficiency in written and spoken English.
Have experience in Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding.

About Company

Sanofi is a leading healthcare company that promotes diversity, equity, and inclusion, providing an environment that supports professional growth and meaningful contributions to healthcare.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

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