Clinical Project Leader

About the job

Join Sanofi Belgium as Clinical Project Leader (CPL). In this role you will be responsible for the set up and progress of a clinical trial/study within the allocated countries, ensuring compliance with company quality standards and regulations in force, the forecasted timelines, milestones and budget.

The CPL is part of the Clinical Study Unit (CSU) and is accountable for the strategic planning & management and performance of their assigned clinical trials from country allocation within feasibility process until study closure inclusive archiving at the CSU level including study timelines, study budget, and study conduct in accordance with Sanofi SOPs and ICH/GCP and regulatory guidelines & directives.

Main responsibilities

• For studies with no Regional Study Manager assigned (mono-country studies, EDOO studies in escalation phase or EDO studies) you may assume partially RSM tasks as needed
• Act on country/cluster level as the key strategic interface with internal and external stakeholders to develop, implement, maintain, and improve operational processes to accelerate trial conduct in close collaboration with respective functions within CSU and other departments, e.g. Medical Advisor, Site Engagement Manager, Strategic Start Up Manager, Medical Science Liaisons
• Act as Person of contact within a therapeutic area in terms of study management and conduct and leads a study team through change management efforts and by example. The LSM represents the LSM perspective for CSU in organization wide initiatives
• Accountable for set-up activities according to the company standards, regulations in force and country generic administrative timelines (submission to ECs/IRBs/HAs, approvals, contracts with sites, local AEDs), and that committed targets and timelines are met at all steps and until study completion (recruitment, active/inactive sites, deadlines for DMCs, DBL, closure of sites, archiving)
• First point of contact for Regional Trial Managers (RTM), other global CTT members and the local monitoring team and first point of contact for Medical Affairs/Business Units for locally initiated studies, providing input to feasibility, study design and budget development and providing feedback on study progress
• Organize kick-off meeting with local monitoring teams (MT), training of monitoring teams (study procedures, study devices, monitoring plan, …) and investigators meetings
• Provide support to MT (protocol, monitoring plan, CRF, tools…)
• Prepare or arranges the preparation of protocols, written subject information, other essential documents, CSR, etc. for studies initiated locally
• Ensure the preparation of local study AED within/across the countries, ensures optimization of costs, and manages the country study budget, Ensure the implementation of study IT systems in the countries (IVRS, ePortal) and adequate provisioning of devices and materials in the countries enough in advance
• Participates in the revision/preparation of study progress tools (newsletters, …)
• Ensures CTMS are updated appropriately (e.g. IMPACT, ClubNet, PRISMA etc.)
• Source and manage service providers for studies initiated locally (e.g. Medical Writer, Statistician, Data Manager, Central Laboratory, CRO, etc.)
• O versee field monitoring activities through regular contacts with local MT (e.g. local CTT meeting), review of MVRs, checks on monitoring tool compliance
• Identify potential problems (risks) and ensures issues are solved with action plans in place (recruitment, study conduct/data quality, …)

About you

• Bachelor’s degree or higher degree in Health or Natural Sciences or equivalent experience depending on the country
• 3 years of experience in clinical research are mandatory, preferably in combination with experience in project management and certain time as field monitor or site coordinator
• Thorough working knowledge of all aspects of GCP and the regulatory/ethical framework pertaining to clinical trials; Ability to plan, set and manage clinical trial budgets
• Ability to learn and apply SOPs
• Good IT skills in, e.g. MS Office, are essential, for planning, tracking, communicating and reporting
• Management, leadership, negotiation skills and communication skills, organizational, analytical and planning abilities, results oriented, quality preserving, be proactive and able to anticipate and resolve conflicts/issues, reactivity to emergent needs, able to prioritize, time management
• Oral and written fluency in English
• Business trip to France, NL or Belgium up to 30%

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.

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

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