Clinical Project Lead
Location: Hyderabad, India
Job Type: Permanent, Full-time
Travel: As per business requirement
Estimated Salary: ₹12 – ₹18 LPA (based on clinical project management experience in India)
About the Role:
Sanofi is looking for a Clinical Project Lead (CPL) who will be responsible for managing the startup, execution, and oversight of rare disease registries. This includes working closely with global registry teams, medical affairs staff, vendors, and internal stakeholders to ensure alignment, compliance, and success across multiple countries. The CPL is a key figure in ensuring clinical excellence, operational effectiveness, and regulatory readiness throughout the project lifecycle.
Key Responsibilities:
Feasibility & Study Start-up:
Participate in country and site selection alongside Registry and Medical Affairs teams.
Arrange supply and coordination of registry materials (Protocols, CRFs, PAFs, etc.).
Facilitate and support execution of financial contracts for study sites.
Project Management & Oversight:
Oversee all registry projects in assigned countries.
Provide regular project status updates to global teams.
Coordinate with CRAs and oversee site visit reports, follow-ups, and site readiness.
Handle data tracking, quality monitoring, vendor communication, and payment status.
Support international data collection initiatives.
Safety, Compliance & Quality:
Ensure compliance with regulatory requirements and SOPs for safety reporting.
Perform risk assessments, root cause analysis, and CAPA implementations.
Maintain inspection/audit readiness at all times.
Training & Administration:
Train or organize training for CRAs and temporary staff.
Maintain trackers, databases, and eTMF documents.
Lead or participate in study meetings, audits, set-up sessions, and operational reviews.
Stakeholder Management:
Communicate effectively with all stakeholders, ensuring alignment on goals, progress, and regulatory matters.
Actively involve stakeholders in project planning and regularly incorporate feedback into continuous improvement.
Performance Objectives:
Lead strategic planning for registry activities.
Ensure regulatory compliance (ICH/GCP, FDA, local).
Identify and mitigate risks to ensure smooth operations.
Drive performance through KPIs, stakeholder satisfaction, and timely project delivery.
Required Qualifications & Experience:
Education: Bachelor’s degree in Pharma, Life Sciences, or a related scientific field.
Experience:
Minimum 5 years in clinical research with 2+ years in clinical project management.
Experience in global/matrixed environments and registry management is essential.
Certifications: Project Management Certification (preferred).
Technical Skills:
Strong knowledge of ICH-GCP, regulatory requirements, and FDA guidelines.
Proficiency in EDC systems, CTMS, and Microsoft Office.
Expertise in data management, risk assessment, and quality control.
Soft Skills:
Strong leadership, stakeholder engagement, and decision-making abilities.
Excellent communication, planning, and problem-solving skills.
Adaptable across cultures and international project dynamics.
Why Join Sanofi?
Be at the forefront of innovation in rare disease research.
Engage in meaningful work that impacts global patient care.
Grow your career in a collaborative, inclusive, and fast-paced environment.
Embrace opportunities for continuous development and recognition.
Ready to lead impactful clinical projects and be a catalyst for healthcare transformation? Apply now and help us chase the miracles of science.
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