Assist with site selection, document collection, and regulatory submissions.
Conduct remote and onsite visits to ensure data accuracy and troubleshoot site issues.
Ensure safety reporting processes, audit readiness, and adherence to protocols.
Maintain study tables, trackers, and databases, ensuring TMF compliance.
Participate in team meetings and contribute to study administration.
Oversee site activities to ensure the collection of accurate, compliant data.

Job Requirements

Strong attention to detail, problem-solving, project management, technical writing, and communication skills.
Degree in Pharma/scientific discipline or related Life Sciences field.
High proficiency in English (spoken and written).
Experience with Causality Assessment, Clinical SAS Programming, 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.
Ability to work independently and as part of a team.

About Company

Sanofi Business Operations (SBO) is centralizing processes to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D globally. The role involves managing and monitoring rare disease registries, interacting with site staff and stakeholders, and overseeing site activities to ensure the collection of accurate, compliant data.

Travel may be required based on business needs.

Sanofi is an equal opportunity employer, fostering diversity, equity, and inclusion in the workplace.

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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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