Clinical Operations and Study Leader (COSL)

4w4 weeks ago

Sanofi

Tokyo, JP · Full-time

About this role

The Clinical Operations and Study Leader (COSL) combines clinical project and study oversight for vaccines projects. This key leadership role directs and manages clinical operational activities to support the Global Clinical Development Strategy Expert and the clinical team. The COSL is accountable for ensuring study activities and clinical deliverables are on time and within budget.

Day-to-day, the COSL serves as the chief liaison between various platforms within GCD and interfaces with enabling functions such as JPH, GPM, GRA, PSPV, and others. This involves working with multiple levels of personnel across regions and external stakeholders like advisory boards and CROs. The role requires an excellent understanding of franchise strategic objectives and Japan regulations.

The COSL ensures effective cross-functional communication and consolidates strategic communication at project and study levels. They support innovation in clinical trial designs, digital methodologies, and tools while fostering an entrepreneurial mindset within the clinical teams. The COSL is also a key player in risk management and crisis coordination for projects and studies.

The COSL is accountable for reliable performance and productivity of clinical projects and studies by leading and coordinating activities and services. This role offers the opportunity to optimize resources and competencies across multiple functions, ensuring alignment with global R&D project strategy. It demands superior interpersonal skills and a strategic operational mindset.

Requirements

Excellent understanding of franchise and project strategic objectives and clinical operational activities
Knowledge of clinical studies constraints including Japan regulations and local requirements
Superior interpersonal skills with ability to work with multiple levels of personnel across many platforms and regions
Proven project management and leadership skills to direct and manage clinical project and study activities
Experience interacting with external stakeholders such as advisory boards, CROs, and regulatory bodies
Understanding of clinical trial designs, digital methodologies, and innovative tools
Ability to synthesize and consolidate strategic communication across project and study levels

Responsibilities

Provide operational input into the clinical project strategy by developing the best operational and scientific approach for successful conduct of the project
Direct and manage clinical operational activities to support the Global Clinical Development Strategy Expert and the clinical team in project and study activities
Ensure study activities and clinical deliverables are on time and within budget, collaborating actively with all functions in the project and clinical teams
Serve as the chief liaison between platforms within GCD and interface with enabling functions such as JPH, GPM, GRA, PSPV, CMQO, GMA, EPI, BSM, and GI for issue resolution
Ensure the Clinical Development Plans are communicated throughout the Extended Clinical Team and the R&D Project Team, aligning with global project strategy
Support innovation and entrepreneurial mindset in clinical trial designs, digital methodologies, and tools within the extended clinical teams
Lead risk management initiatives and coordinate crisis management within the project or studies