Sanofi
ClinicalOperationsandStudyLeader
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Clinical Operations and Study Leader at Sanofi. Skills: Clinical Operations, Study Leadership, Project Management, Cross-functional Coordination. Combine Clinical project and study oversight roles. Direct and manage clinical operational activities”
What You'll Achieve.
Ensure study activities and clinical deliverables are on time; Ensure study activities and clinical deliverables are within budget; Ensure reliable performance of Clinical project/studies; Ensure reliable productivity of Clinical project/studies; Ensure project deliverables within GCD; Ensure study deliverables within GCD; Ensure timelines; Ensure quality; Ensure budget; Ensure Clinical project performance meets expectation; Ensure study progress is aligned with projections; Meet study timelines
Industry & Context.
Issue resolution; Risk management; Crisis management; Innovative problem solving
What They're Looking For.
Must Have
Master degree in relevant scientific and/or medical field, Minimum of 8 years’ experience in clinical research, Very project management experience, Proven track record of effectively leading multifunctional teams, Project Management Skills, Clinical Trial experience, Business acumen, Excellent organizational skills, Excellent interpersonal skills, Excellent communication skills (verbal & written), Communication skill in Local language, Communication skill in English, Adequate knowledge of local requirements, Customer and quality focused, Capability to effectively handle large complicated global projects, Ability to drive decision making process, Innovative problem solving, People management skills, Change management skills, Influence management skills, Ability to set and manage expectations, Ability to resolve conflict, Negotiations skills, Culturally savvy, Leadership in a multicultural environment, Familiarity with project management software
Nice to Have
Experience with digital methodologies, Experience with digital tools
What You'll Do.
Combine Clinical project and study oversight roles
Direct and manage clinical operational activities
Support Global Clinical Development Strategy Expert
Support clinical team in project and study activities
Ensure study activities and clinical deliverables are on
Ensure study activities and clinical deliverables are within
Collaborate with all functions in the project and
Act as chief liaison between various platforms within
Act as interface with other enabling functions
Work with multiple levels of personnel
Work with external stakeholders
Optimize integrate and utilize team’s resources and competencies
Provide expertise to develop operational strategy
Ensure successful conduct of the project
Ensure delivery of the studies
Understand franchise/project strategic objectives
Understand clinical operational activities
Understand clinical studies constraints
Understand Japan regulations
Ensure effective cross functional communication
Consolidate strategic communication at project level
Consolidate strategic communication at study level
Support innovation and entrepreneurial mindset
Support new clinical trial designs
Support new digital methodologies
Support new digital tools
Support new organization within teams
Coordinate crisis management within the project/studies
Ensure reliable performance of Clinical project/studies
Ensure reliable productivity of Clinical project/studies
Lead project and studies activities
Coordinate project and studies activities
Ensure project deliverables within GCD
Ensure study deliverables within GCD
Provide operational input into clinical project strategy
Provide expertise to develop operational strategy
Provide expertise to develop scientific strategy
Understand overall project strategy
Understand franchise strategy
Provide support for clinical project governance
Ensure Clinical Development Plans are communicated
Ensure alignment with R&D global project strategy
Ensure Clinical project performance meets expectation
Contribute to ensure harmonization of activities
Contribute to ensure alignment between local and global
Manage planning of clinical study/project/program execution
Manage feasibility of clinical study/project/program execution
Develop planning of clinical sections of regulatory submissions
Drive execution of clinical sections of regulatory submissions
Communicate status updates for regulatory submissions
Monitor projects’ progress
Monitor projects’ performance
Ensure proactive reporting on program management components
Ensure timely reporting on program management components
Escalate issues that require input from Clinical Management
Escalate issues that require discussion with Clinical Management
Organize study specific meetings
Ensure study operational feasibility is properly done
Consider study operational feasibility with other functions
Integrate feedback in study plan
Integrate feedback in study risks
Ensure study progress is aligned with projections
Coordinate information on clinical timelines
Update CSC Order Management tool
Address potential time slippage
Coordinate clinical team’s plans to meet study timelines
Ensure Clinical Team communication is properly set-up
Ensure proper setup of Trial Management tools
Ensure adequate management of study documentation availability
Ensure adequate management of tool access
Collect study information
Synthesize study information
Report study information
Participate in selection of vendors
Participate in management of vendors
Participate in development of vendor budget
Participate in follow-up of vendor budget
Accountable for preparation of study budget
Accountable for follow-up of study budget
Collaborate to preparation of study audits
Collaborate to oversight of study audits
Collaborate to preparation of pre-approval inspections
Collaborate to oversight of pre-approval inspections
Collaborate to preparation of inspections
Collaborate to oversight of inspections
Consolidate strategic communication at program level
Maintain cross functional communication
Act as an interface between Extended Clinical Teams
Act as an interface between Clinical Teams
Act as an interface with other enabling functions
Stay abreast of advances in area of expertise
How You'll Work.
Team & Collaboration
Cross-functional teams; Extended Clinical Team; R&D Project Team; Clinical Management; Other enabling functions; Various platforms
Communication Scope
Cross functional communication; Strategic communication; Verbal communication; Written communication; Status updates
Process & Methodology
Project management, Study management, Program management, Clinical project strategy, Clinical project governance, Clinical Development Plans, R&D global project strategy, Clinical project performance, Harmonization of activities, Feasibility of execution, Regulatory submissions, Projects progress monitoring, Program management components, Study operational feasibility, Country selection, Recruitment potentials, Budget needs, Clinical timelines, Study timelines, Trial Management tools, Study documentation, Vendor management, Operational experts, Study budget, Study audits, Pre-approval inspections, Inspections, Cross functional communication, Strategic communication, Risk management, Crisis management, Project deliverables, Study deliverables, Timelines, Quality, Budget, Japan regulations, Interpersonal skills, Business acumen, Transversal leadership, Strategic leadership, Cross functional team leadership, Team motivation, Interpersonal skills, Collaboration with customers, Managing expectations, Self-motivation, Results driven, Organizational skills, Conflict resolution, Negotiation skills, Cultural savviness, Positive mindset, Team spirit, Leadership, Multicultural environment
Full Job Description
**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 commun
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