Global Clinical Study Manager – Sanofi Consumer Healthcare
Based Reading, Berkshire or at other CHC locations across Europe
About the Opportunity:
An exciting opportunity has arisen to join the Consumer Healthcare team as our Clinical Study Manager where you will be responsible for the operational planning, management and execution of clinical studies and programs(s) within the Clinical Operations Science Hub.
The clinical study management team manages the delivery of the global evidence generation portfolio that includes both clinical and non-clinical projects as well as interventional and non-interventional projects.
You are the leader of the clinical study team and are empowered to drive the management and delivery of the study team operational objectives, ensuring all study deliverables are met according to the study timelines, within budget and in compliance with internal (SOP’s / QD’s) and external standards (ICH, GLP).
About Sanofi Business Unit
At Sanofi CHC, we have one shared purpose – we work passionately, every day, to ‘serve healthier, fuller lives. Our marketing philosophy is driven by this purpose and everything we do is centred around people – our consumers, our customers, healthcare professionals, and our employees – across the world.
We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Consumer Healthcare company. We want to be market shapers and achieve category leadership in the categories that we play in – delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example.
As a top 3 global CHC player, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect and integrity.
We have recently announced an exciting 18-24 month journey to create a fully standalone CHC business (separating the Business Unit from our Pharma company heritage, processes etc), as we target to create the best FAST MOVING CONSUMER HEALTH company, which will require us to retain, attract and grow the best leaders in our industry.
Key Responsibilities:
The GCSM leads:
- the preparation of study related plans and materials, identification of study risks and contingency planning, appropriate escalation of issues, monitors the study planning, manages budget to ensure it is kept within budget and leads the execution of the study with integrity and suitable for regulatory review.
- the cross-functional study teams: responsible for the coordination of internal/ external resources, organization of internal team meetings, s/he drives and oversees CROs and vendors for the flawless execution of studies. The GCSM is responsible for the oversight of the selected CRO and Clinical Service Providers and set up of the required CRO and vendor oversight documentation to ensure adherence to scope of work within timelines and budget.
- independently multiple studies, projects, or phases of a larger project / higher TA complexity (i.e., accelerated timelines, complex operational study designs and/or high number of complex vendors) and effectively builds relationships with internal and external project stakeholders to ensure seamless transition of the project(s) as they progress through development plan, when necessary.
- the cross functional study team (including representatives from CROs/affiliates/vendors etc. Medical study experts, Biostatistics, Clinical Supplies, Regulatory, Pharmacokinetics experts, Pharmacovigilance and other relevant departments) for the operational aspects of the study.
- Liaises with the selected CRO to review and assess feasibility.
- Liaises with clinical buyers to prepare the RFP (request for proposal), review the proposal, participate in the selection of the vendor(s).
- Liaises with procurement for vendors’ activities and deliverables, and directly oversees activities and deliverables for vendors not covered by procurement, to ensure performance expectations are met.
- Liaises with the lead Study Project Manager (PM) from the selected CRO on the contractually agreed scope of work and deliverables.
- Ensures study progress is aligned with the projections: drive and oversee study timelines, track budget, escalate risk to timelines and budget as needed.
- Communicates changes and progress.
- Reviews the following key study documents provided by the selected CRO/vendor: Monitoring Plan; Study Communication Plan; Study Risk Management Plan, and any study operational material (e.g., Study newsletters, memo, etc.) as needed.
- Co-develops documents with vendors (if procurement is not involved): specifications of central services, scope of work, operational manual, etc. in collaboration with the study team.
- Reviews further study related documents developed with the study team and CRO including study outline, study protocol, amendments, eCase Report Form, CRF completion guidelines, eTMF filing plan, Sponsor Oversight Plan, Study Risk management plan, subject recruitment and retention plan, committee charters and/or other operational documents as requested to provide operational input (including on-time and high quality).
- Ensures study documentation is properly maintained and archived in the electronic Trial Master File (eTMF).
- Organizes and leads the core and extended study team meetings, including risk management discussions with cross-functional team throughout the study lifecycle.
- Organizes and leads meetings/ TCs with local team representatives to oversee study progress.
- Ensures the training of the CRO/vendor staff, participates in investigator meetings.
- Organizes and leads meetings/TCs with CROs/vendors (for vendors not managed by procurement).
- Contributes to data cleaning, data review meetings.
- Maintains and provides information for monthly study reports (including enrolment curves, timelines, analysis of the study status and identification of potential risks) in close cooperation with the selected CRO.
- Collaborates with the Clinical Supplies CRO/vendor to validate IMP needs, shipment (including resupply) and reconciliation process.
- Defines needs, tasks and responsibilities of external CROs/vendors, participates in bid defence meeting, reviews contracts, estimates costs of logistical aspects of the study and ensures tracking payments for operational aspects of the study in collaboration with the Clinical buyers from procurement.
- Develops and tracks the overall study budget in close cooperation with the selected CRO and vendors if applicable.
- Monitors the budget during the study, making forecasts and following expenses/ accruals, identify and evaluate complementary needs. Performs final budget reconciliation with CRO and vendors at study end.
- Ensures preparation and proper responses to audit/inspection reports for findings associated to GCSM, ensures discussions are held with study team members, with regard to important observations to develop and implement immediate action plans at CRO and vendor level if needed.
- Ensures inspection-readiness during the study in close cooperation with the selected CRO and vendors.
About You:
To excel in this role, you will need to have:
Qualifications
- Bachelor’s degree in Science (advanced degree preferred).
Experience
- Proven experience in managing clinical trials in pharmaceutical companies or CROs.
- Clinical experience and expertise are highly desirable.
- Experience in Consumer Health Care (CHC) is highly desirable.
- Knowledge of international standards (e.g., ICH-GCP, CDISC, etc.).
- Knowledge of company tools, processes, and SOPs.
- Strong working knowledge of Microsoft Office 365.
- Solid Project Management background.
- Experience in oversight on outsourced study activities covering all study periods from start-up to study report and eTMF completion.
- Ability to develop and maintain an optimized study planning with other functions (including identification of critical path).
- Ability to coordinate multiples interfaces: (e.g.) studies including several vendors.
- Ability to work autonomously, to efficiently and effectively provide status reports.
- Ability to appropriately delegate responsibilities (e.g., internally – when several GCSM involved on a study/externally – in case of outsourced activities.
Language skills:
- Fluent spoken and written English.
- An Additional language is desirable.
What Sanofi can offer you:
- A role where you are instrumental to creating best practice and as the organisation grows, you can too.
- We offer a generous package including flexible benefits and are committed to helping you have a healthy work-life balance throughout your career with us.
- We are based in Reading, Thames Valley Park and offer flexible working.
Thank you for your interest in Sanofi and we look forward to hearing from you!
About Sanofi:
Empower Life Everyday
At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.
Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.
The values we are live by are teamwork, courage, respect and integrity
Visas for those who do not already have the right to work in the UK will be considered on a case by case basis according to business needs and resources.
We are proud to have been awarded Global Top Employer 2021.
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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.