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Clinical Project Lead

5+ years
Not Disclosed
10 Feb. 6, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: 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, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Project Lead
Location: Hyderabad, India
Type: Permanent
Posted on: Jan. 31, 2025
Closing on: Mar. 27, 2025

About the Job

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.

Responsibilities:

  • Feasibility: Involve in country and site selection, working with the Registries and Local Medical Affairs teams.
  • Study Start-up: Organize study materials, ethical, and regulatory submissions; ensure contracts and financial agreements.
  • Project Management: Maintain oversight of Registries, coordinate with Clinical Research Associates (CRAs), monitor contract issues, and track data quality. Provide status updates to the Global Registries Team.
  • Safety & Quality: Ensure safety reporting and quality control, implementing Corrective and Preventive Actions (CAPA) as needed.
  • Study Administration: Oversee training, maintain study tracking tools, and contribute to TMF compliance.
  • Stakeholder Management: Communicate effectively with stakeholders, providing updates and resolving issues promptly.

Qualifications:

  • Experience: 5+ years in Clinical Research, with at least 2 years in project management.
  • Education: Degree in Pharma/scientific or related Life science discipline.
  • Skills: Strong problem-solving, project management, communication, and leadership skills.
  • Technical Skills: Proficiency in CTMS, EDC systems, and data management.
  • Languages: High proficiency in English.

Additional Information:

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