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About the Role

The Clinical Operations and Study Leader (COSL) combines clinical project and study oversight roles for Vaccines projects. This leadership role directs and manages clinical operational activities, ensuring study activities and deliverables are on time and within budget. The COSL acts as a liaison between various platforms within GCD and interfaces with other enabling functions, coordinating crisis management and ensuring reliable performance of clinical projects and studies.

Responsibilities

Provides operational input into the clinical project strategy.
Ensures Clinical Development Plans are communicated throughout the Extended Clinical Team and the R&D Project Team.
Accountable for Clinical project performance to ensure it meets expectations with respect to timelines, quality and budget.
Contributes to ensure harmonization of activities in between studies within a program and transversally and across clinical projects/programs.
Manages the planning and feasibility of execution of the clinical study/project/program.
Develops the planning and drives execution of the clinical sections of the required regulatory submissions.
Monitors projects’ progress and performance against strategic objectives and key performance indicators.
Ensures proactive, timely reporting on progress of program management components of clinical trials.
Organizes study specific meetings.
Ensures study operational feasibility is properly done and considered.
Ensures study progress is aligned with the projections.
Ensures the Clinical Team communication is properly set-up.
Ensures proper setup of Trial Management tools and adequate management of study documentation availability and tool access.
Collects, synthesizes and reports study information.
Participates in selection and management of vendors and operational experts.
Is accountable for preparation and follow-up of study budget.
Collaborates to the preparation and oversight of study audits/ pre-approval inspections (PAI)/inspections.
Consolidates strategic communication at project/program level and maintains cross functional communication.
Acts as an interface between the Extended Clinical and Clinical Teams and other enabling functions.
Ensures oversight of the CRO involved in the monitoring of the study.
Ensures effective cross-regional communication to allow clinical teams to function efficiently.
Arranges scientific advisory boards, adjudication committees and experts committees.
Is a member of R&D project, extended clinical, and clinical teams member for assigned projects.
Actively engages in decision-making process with other stakeholders in GCD.
Provides guidance on best practices and lessons learned for operational execution of clinical trials.
Facilitates operational issue resolution.
Leads risk management initiatives for the clinical project.
Coordinates crisis management within clinical project/program.
Mentors team members to develop enhanced leadership skills.
Encourages and supports team member empowerment.
Ensures appropriate project level capacity/resource planning and management.
Consolidates and review budget and resources allocation for clinical project/study activities.
Is accountable for tracking and monitoring the project/program budget.
Supports innovation and entrepreneurial mindset such as clinical trial designs, digital methodologies and tools.
Establishes culture of continuous learning and improvement in the clinical project.
Identifies process issues requiring resolution at the project level and proposes solutions.
Identify opportunities for improving organizational processes.
Ensures that ‘lessons learned’ approach is built into the review and adoption of new approaches and methods.
Stays abreast of advances in his/her area of expertise.

Requirements

At least Master degree in relevant scientific and/or medical field.
A minimum of 8 years’ experience in clinical research in pharmaceutical industry.
Very strong project management experience is required.
A proven track record of effectively leading multifunctional teams is needed.
Strong project management skills.
Transversal and strategic leadership capabilities.
Communication skills.
Business acumen.
Ability to drive a high performing cross functional team that empowers and motivates individual members and the team.
Strong interpersonal skills required to effectively collaborate with customers and interfaces to set and manage expectations.
Clinical Trial experience required.
Excellent organizational, interpersonal and communication skills (verbal & written).
Strong communication skill in Local language and in English with adequate knowledge of local requirements.
Customer and quality focused.
Capability to effectively handle large complicated global projects that integrates various disciplines.
Proactive with ability to drive decision making process.
Innovative problem solving.
People, Change and Influence management skills.
Ability to set and manage expectations.
Self-motivation, results driven, detail-oriented and good organizational skills.
Ability to resolve conflict.
Strong negotiations skills.
Culturally savvy.
Positive mindset and behavior – Strong team spirit.
Leadership in a multicultural environment.
Familiarity with project management software.

Skills

Project Management Skills
Clinical Trial experience
Business acumen
Organizational skills
Interpersonal skills
Communication skills (verbal & written)
Customer and quality focused
Problem solving
People management
Change management
Influence management
Negotiations skills
Leadership
Project management software

Experience Level

Minimum of 8 years’ experience in clinical research

Education Level

Master degree in relevant scientific and/or medical field

About the Company

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Equal Opportunity

Sanofi provides equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.