Clinical Project Lead

5-7 years

Not Disclosed

10 Feb. 11, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 / Bogota
Job Type: Permanent, Full-time
% of Travel Expected: Travel required as per business need

About Us:

Sanofi Business Operations (SBO) is an internal resource organization dedicated to centralizing processes that support multiple global functions, including Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. SBO aims to reduce reliance on external providers and foster the development of internal expertise, enabling us to deliver strategic and tactical support across various business units globally.

Job Overview:

As a Clinical Project Lead (CPL), you will be responsible for managing and overseeing rare disease registries in collaboration with the Registry Team and Medical Affairs staff. You will ensure that these registries comply with company SOPs, local regulations, and sponsor guidelines. Your responsibilities will include managing registry feasibility, start-up, and project management activities, as well as maintaining oversight of registries across assigned countries.

Main Responsibilities:

Feasibility Activities:

Involve in country and site selection in collaboration with the Registry Team and Local Medical Affairs.

Study Start-up Activities:

Arrange the supply of necessary registry materials, such as protocols, CRFs, PAFs, for regulatory and ethical submissions.
Ensure the execution of financial contracts for each site and assist with the contracting process.

Project Management:

Manage all registries within assigned countries and maintain country-level oversight.
Provide regular country status updates to the Global Registries Team.
Collaborate with Clinical Research Associates (CRAs) for site management.
Monitor contract issues and coordinate payments based on payment milestones with the Finance team.
Ensure high-quality data management and monitoring.
Coordinate international data collection projects.

Safety & Quality:

Ensure safety reporting processes comply with country regulations and SOPs.
Conduct quality control at the country level, ensuring "audit/inspection readiness."
Perform root cause analysis of deviations and implement CAPA as necessary.

Study Administration:

Train or arrange training for new CRAs and additional temporary resources.
Maintain project tracking tables, databases, and tools.
Contribute to internal process improvements, CAPA, and Quality Management System (QMS) documents.
Ensure TMF compliance throughout the study lifecycle.

Study Meetings:

Participate in local and international investigators' meetings, operational meetings, quality audits, and study set-up trainings.

People & Stakeholder Management:

Seek alignment with internal and external stakeholders to prioritize registry study activities and ensure compliance with processes.
Actively engage stakeholders, address concerns, and gather feedback for continuous improvement.

Performance Management:

Develop and execute comprehensive plans for registry initiation, execution, and completion.
Lead cross-functional teams and ensure alignment with project goals and timelines.
Ensure compliance with national and international regulatory requirements, including ICH/GCP.
Monitor and evaluate registry performance and make necessary adjustments for success.

Process Management:

Coordinate the registry start-up and oversight in collaboration with internal and external teams.
Monitor data quality, contracts, and financial status.
Manage and implement corrective actions for issues related to study conduct.

Qualifications & Requirements:

Experience:

5+ years of experience in clinical research & development, including at least 2 years in clinical trial project management.
Project management certification preferred.
Experience in managing global projects in an international matrix environment.

Soft Skills:

Excellent written and verbal communication skills.
Strong organizational and project management abilities, with a focus on meeting deadlines and stakeholder management.
Demonstrated ability to work effectively across diverse cultures and countries.

Technical Skills:

Strong understanding of ICH-GCP principles and local regulatory requirements.
Proficiency in CTMS for tracking and managing registry activities.
Familiarity with EDC systems for data management and analysis.
Ability to assess and mitigate risks throughout registry execution.
Competent with Microsoft Office products.

Education:

Degree in a pharmaceutical/scientific discipline or related life science field, with significant experience in project management, clinical trials, and drug development.

Languages:

High proficiency in written and spoken English.

Why Join Us?

Career Growth: Discover numerous opportunities for personal and professional development in a global organization.
Rewarding Package: Enjoy a comprehensive benefits package designed to support you and your family’s health, wellbeing, and work-life balance.
Diversity & Inclusion: Sanofi is an equal opportunity employer committed to fostering an inclusive workplace.
Innovative Environment: Join a team focused on driving scientific progress and improving patient outcomes globally.

How to Apply:

If you are passionate about improving global healthcare through clinical project leadership and meet the qualifications outlined above, we encourage you to apply and be a part of our mission to make extraordinary progress in healthcare.

Pursue progress. Discover extraordinary.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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