Oversee country and site selection, working with the Registries and Local Medical Affairs teams.
Organize study materials, ethical and regulatory submissions, and ensure contracts and financial agreements.
Maintain oversight of Registries, coordinate with Clinical Research Associates (CRAs), monitor contract issues, and track data quality.
Ensure safety reporting and quality control, implementing Corrective and Preventive Actions (CAPA) as needed.
Communicate effectively with stakeholders, providing updates and resolving issues promptly.
Contribute to TMF compliance and maintain study tracking tools.

Job Requirements

A degree in Pharma or a scientific Life science discipline is required.
Strong problem-solving, project management, communication, and leadership skills are essential.
Proficiency in CTMS, EDC systems, and data management is necessary.
High proficiency in English is expected.
Experience in Causality Assessment, Clinical SAS Programming, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, and Research & Development is preferred.
Ability to work within regulatory guidelines and SOPs to manage study activities from feasibility to quality assurance.

About Company

Sanofi Business Operations (SBO) seeks a Clinical Project Lead (CPL) to oversee Registries in close collaboration with the Registry Team and Medical Affairs. The CPL will be responsible for rare disease registries and work within regulatory guidelines and SOPs to manage study activities from feasibility to quality assurance.

Sanofi embraces diversity, equity, and inclusion, and provides equal opportunities to all individuals regardless of background.

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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