Clinical Trial Manager, Belgium

Sanofi

Ver: 160

Día de actualización: 16-11-2025

Ubicación: Ghent East Flanders

Categoría: R & D Planificación / Proyectos Ciencias

Industria: Pharmaceuticals Chemicals Biotechnology

Posición: Mid-Senior level

Tipo de empleo: Full-time

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Contenido de trabajo

About The Opportunity

Join Ablynx, a Sanofi company as a Clinical Trial Manager (CTM) responsible for the overall operational planning and implementation and conduct of early clinical development clinical trials in Belgium. This could include clinical exploratory pharmacology (including first in human), and proof of concept clinical trials in compliance with all internal and external guidelines and requirements.

As a CTM you will also acts as the leader of operational disciplines to guarantee release of homogeneous high quality clinical data in close collaboration with the Data Manager and Clinical Study Director.

About Ablynx, a Sanofi Company

Ablynx, a Sanofi company, is engaged in the development of NANOBODY® proteins, proprietary therapeutic proteins based on single-domain antibody fragments, which combine the advantages of conventional antibody drugs with some of the features of small-molecule drugs.

NANOBODY® proteins have potential uses in the treatment of a range of serious and life-threatening human diseases. Ablynx advances a portfolio of NANOBODY®-based therapeutic programs in several major disease areas, including inflammation, haematology, immuno-oncology and oncology.

About Growing With Us

In this role you will….

  • Lead the Clinical Trial Team (CTT) including representatives of all operational disciplines involved in the conduct of trial (i.e., CRAs/CROs, Data Management, Pharmacovigilance, Clinical & Exploratory Pharmacology Sciences, Biostatistics, Pharmacokinetics, Clinical Supplies, and other relevant departments, platforms or units).
  • Manage the study according to Good Clinical Practices (GCPs) and local and/or national regulations, with responsibilities on product and project level.
  • Collaborate with team members on a day-to-day basis; in particular, build a strong collaboration with the study Data Manager (DM) and the Clinical Study Director (CSD).
  • Develop and coordinate the study budget, including invoice validation.
  • Manage CRO/study sites. Escalate quality issues and delays in deliverables, propose solutions, request and ensure follow-up actions. Assess CRO performance by completing CRO post services assessments.
  • Oversee site visits (Site Initiation Visit, Interim Monitoring Visits, Closure Visit) including in-house preparation such as data listings review.
  • Participate to the mentoring and training/coaching of Associate CTMs, apprentices or trainees.

About You

Qualifications/ Education & work experience

  • Master’s degree education
  • 5+ years Clinical Research experience within a matrix organization (general understanding of R&D processes including the principals of study design and execution)
  • 3-5 years Field Monitoring experience or related experience - required
  • 3-5 years Clinical Trial Management or Project Management experience
  • Previous Phase I experience - preferred
  • Knowledge of and understanding of medical terminology and GCP/ICH guidelines
  • Ability to effectively collaborate with scientists, managers from various disciplines as well as external partners in an international and multicultural environment
  • Experience with management of outsourced activities
  • Strong interpersonal and communication skills
  • Results driven, goal oriented, self-motivated, organized, flexible team player with attention to detail
  • Knowledge of data management activities. Experience with various computer systems/databases and willingness to learn about new systems/databases
  • Oral and written fluency in English

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!

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.

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Plazo: 31-12-2025

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