Clinical Operations and Study Leader

Summary of purpose/major responsibilities

The Clinical Operations and Study Leader (COSL) combines Clinical project and study oversight roles and responsibilities for Vaccines projects activities.

For projects activities (project and study oversight, CTD submission, PAI…), the COSL will cover both COL and GSM activities.

The COSL is a key leadership role within the assigned project. The COSL directs and manages clinical operational activities to support the Global Clinical Development Strategy Expert (GCDSE) and the clinical team in project and study activities.

She/he is accountable for ensuring study activities and clinical deliverables are on time and within budget, collaborating actively with all functions in the project and clinical teams as well as functions in Clinical.

The COSL is the trusted and reliable chief liaison between the various platforms within GCD and acts as well as an interface with other enabling functions such as JPH, GPM, GRA, PSPV, CMQO, GMA, EPI, BSM, and GI, especially in the context of issues resolution. Therefore, it involves working with multiple levels of personnel from many platforms, in multiple regions, as well as with external stakeholders (e.g., advisory boards, CROs).

The COSL is accountable for ensuring the deliverables of the clinical project and/or studies activities via effective project management and leadership skills in a manner that will optimize integrate and utilize the team’s resources and competencies.  The COSL will support the clinical project and studies strategy by providing expertise to develop the best operational strategy for the successful conduct of the project and delivery of the studies. It requires an excellent understanding of franchise/project strategic objectives, clinical operational activities, and clinical studies constraints including Japan regulations, as well as superior interpersonal skills.

The COSL ensures an effective cross functional communication and consolidates strategic communication at project level as well as study level.

The COSL supports innovation and entrepreneurial mindset such as clinical trial designs, digital methodologies, and tools as well as organization within the extended clinical and clinical teams.

The COSL is a key role in risk management initiatives and coordinates crisis management within the project/studies.

The chief accountability is to ensure reliable performance and productivity of Clinical project/studies by leading and coordinating project and studies activities and services.  Accountable for both project and study deliverables within GCD, including the timelines, quality and budget .

Key accountabilities

Project strategy and coordination

Provides operational input into the clinical project strategy by providing expertise to develop the best operational and scientific strategy for the successful conduct of the project. Knowledgeable about and understands overall project and franchise strategy.

In collaboration with the GCDSE, provides support for clinical project governance.

Ensures the Clinical Development Plans are communicated throughout the Extended Clinical Team and the R&D Project Team and to ensure alignment with R&D global project strategy.

Accountable for Clinical project performance to ensure it meets expectation with respect to timelines, quality and budget.

Contributes to ensure harmonization of activities (operational strategy) in between studies within a program and transversally and across clinical projects/programs, as well as alignment between local and global.

Manages the planning and feasibility of execution of the clinical study/project/program performed as part of the Clinical Development Plan.

Develops the planning and drives execution of the clinical sections of the required regulatory submissions and communicates status updates (i.e. CTD, eBLA, PAI, and others as appropriate).

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, openly escalate issues that require input from and discussion with members of Clinical Management.

May be responsible for more than one clinical project, and/or clinical studies depending on project scope and individual experience.

**Coordinates the Clinical Team with the GCDSE for the operational aspects of the study:

- Organizes study specific meetings

- Ensures study operational feasibility is properly done and considered working with other functions and integrates feedback in study plan and risks (GRA timelines, country selection, recruitment potentials, budget needs).

- Ensures study progress is aligned with the projections: coordinates information on clinical timelines from all contributors (including IMP and NIMP by updating the CSC Order Management tool), proactively addresses potential time slippage and coordinates the clinical team’s plans to meet the study timelines.

- 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, development and follow-up of the associated budget when needed

** Is accountable for preparation and follow-up of study budget

** Collaborates to the preparation and oversight of study audits/ pre-approval inspections (PAI)/inspections

Communication/Interfaces

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 such as GRA, PSPV, CMQO, GMA, EPI, PPFP and GI, especially in the context of issues resolution.

Ensures oversight of the CRO involved in the monitoring of the study.

Ensures effective cross-regional communication to allow clinical teams to function efficiently to achieve global plans.  Ensures top down/bottom-up communication.

In collaboration with the GCDSE arranges scientific advisory boards, adjudication committees and experts committees, set up, follow-up, communication and manages partnership/alliance with experts.

Leadership

Is a member of R&D project (including local), extended clinical, and clinical teams member for assigned projects.

Actively engages in decision-making process with other stakeholders in GCD, providing input as needed to Head, GCD and Global Heads of clinical platforms.

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 to minimize negative impacts to team deliverables.

Coordinates crisis management within clinical project/program and interface with Clinical platforms and beyond to define and implement action plan.

In collaboration with team member’s manager, mentors team members to develop enhanced leadership skills such as consensus-building and conflict resolution. Encourages and supports team member empowerment. Is a trusted liaison for Clinical and other stakeholders across platforms and functions.

Budget

Ensures appropriate project level capacity/resource planning and management in conjunction with other functions within GCD.

Consolidates and review budget and resources allocation for clinical project/study activities through transversal reviews and interact with BO, FP and R&D Finance to ensure the Clinical budget and planning is accurate.

Is accountable for tracking and monitoring the project/program budget with support of BO.

Learning/continuous improvement

Supports innovation and entrepreneurial mindset such as clinical trial designs, digital methodologies and tools as well as organization within the clinical project/program.

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 to continue to drive organizational excellence

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

Education/experience:

At least Master degree in relevant scientific and/or medical field and 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.

Certifications:

Strong project management skills, transversal and strategic leadership capabilities, communication skills and business acumen are required.  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 (physicians, scientists and managers from various disciplines) and interfaces to set and manage expectations.

Project Management Skills

Clinical Trial experience required

Business acumen

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

Selling Points:

1. Cross-functional Leadership: COSL coordinates global teams to ensure seamless clinical trial execution and strategic alignment.

2. Project Management Expertise: Ensures clinical trials meet timelines, budgets, and quality standards, aligning with global objectives.

3. Innovation and Improvement: Drives adoption of new trial designs and digital solutions, fostering efficiency and team development.

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