Clinical Project Lead

About the Opportunity

Join Sanofi Belgium as a Clinical Project Lead(CPL) to support our priority pipeline covering Rare Diseases, Biologics, Neurology and Oncology projects. You will be responsible for the set up and execution of clinical trials in Belgium and Luxembourg ensuring compliance with company quality standards and regulations in force, the forecasted timelines, milestones and budget.

As a CPL you will be the primary contact for the Regional Trial Manager (RTM) and other CSU colleagues to lead the monitoring teams (MT) for local studies. You will also represent the CSU at the Medical Affairs/Business Unit meetings to provide feedback on study progress.

If you have proven clinical trial design experience, enjoy managing multiple projects and looking to join a global healthcare leader - we would like to hear from you!

About Sanofi

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. We want to focus on those areas where we know we are making a difference.

About growing with us

In this role you will….

• Take accountability for setting-up activities according to company standards, regulations in force and generic administrative timelines and that committed targets and timelines are met at all stages until study completion (recruitment, active/inactive sites, deadlines for Data Monitoring Committees (DMC), Database Lock (DBL), closure of study sites, archiving)

• Act as first point of contact for Regional Trial Managers (RTM), other global CTT members and the local monitoring teams. Also you are the 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

• Collaborate with the Medical Advisors and Site Partnership Manager to identify potential Investigators and take an active role in the completion of the site selection visits

• Organize start-up planning and kick-off meetings with the MT including Support Functions

• Provide support to MT (protocol, monitoring plan, CRF, tools…) and prepare or arrange the preparation of protocols, written subject information, other essential documents, CSR, etc. for studies initiated locally

• Oversee field monitoring activities through regular contacts with the MT; ensure regular and optimal communication/interaction with CRAs

• Ensure preparation of audit/inspection reports and implementation of recommendations in cooperation with the Clinical Quality Team; ensure inspection readiness with appropriate oversight and quality checks of the Local Study File; share lessons learned and ensure adequate deployment of possible identified action points for improvement within/across NOBA

About you

Qualifications/ Education & work experience

• Degree in science or medical specialty

• 5+ years professional experience in Clinical Development (e.g. as CRA)

• Proven clinical trial design and development knowledge and experience in relevant therapeutic areas

• Ability to learn and apply SOPs

• Thorough working knowledge of all aspects of GCP and the regulatory/ethical framework pertaining to clinical trials; ability to learn and apply processes as per Quality Documents

• Ability to manage multiple trials in different therapeutic areas; ability to plan, set and manage clinical trial budgets

• Ability to escalate non-performance and quality issues to local management, CQPTA (quality issues) and RTM

• Management, leadership, negotiation and communication skills

• Strong analytical and planning skills; proactive, results oriented with an ability to anticipate and resolve conflicts/issues, good time management and prioritization skills with an ability to work under pressure whilst meeting tight deadlines

• Act for change, strive for results, cooperate transversally, commit to customers, make decisions, lead others through people/ project management

• Good IT skills in, e.g. MS Office, are essential, for planning, tracking, communicating and reporting

• Oral and written fluency in English, French and Dutch

Inspire your Journey: what Sanofi can offer you:

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.

• An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (e.g. company pension plans, health management).

• An individual and well-structured introduction and training when you onboard.

• You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.

• As a globally successful and constantly growing company, Sanofi provides international career paths as well.

This is our Sanofi. Discover yours.

If you feel you have the required experience please apply NOW, alternatively contact maria.kmetyova-ext@sanofi.com directly for more details.

https://www.sanofi.com/en/careers/

Own your future. Make your move!

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.