About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Main Responsibilities
- Coordinate and oversee the full clinical site lifecycle (initiation, activation, monitoring, close-out) across all participating centers, under delegation of the Clinical Project Manager (CPM).
- Draft key study documents such as the Monitoring Plan, internal manuals, and center-facing guides (e.g., for randomization and treatment unit management).
- Supervise and support CRAs involved in the study: training, visit scheduling, on-site and remote monitoring supervision, review and approval of reports.
- Ensure regulatory and operational compliance throughout the study in line with protocol, SOPs, and ethical standards.
- Monitor study progress using tools like the Clinical Trial Management System (CTMS) and oversee maintenance of the Trial Master File (TMF).
- Lead communication with sites via the CRA team: share newsletters, study updates, recruitment status, and protocol changes.
- Contribute to study setup activities: database (eCRF) design, risk assessments, resource planning, and coordination with study centers.
- Support centralized medical monitoring and participate in review of protocol deviations and study risk mapping.
- Oversee close-out activities: TMF completion, final quality checks, visit planning, and archiving.
- Collaborate cross-functionally, report to hierarchy, and contribute to departmental meetings and collaborative initiatives.
Requirements
About You
At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.
- Experience: Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum years—talent matters most to us!)
- Skills: Proven track record as a CRA and at least 1–2 years in a coordination or lead role, Experience working within TMF and CTMS systems, Skilled in centralized monitoring, risk-based monitoring, and quality review.
- Education: Scientific degree in life sciences, pharmacy, or nursing (Master’s degree or equivalent preferred).
- Languages: French and good skills in English
Benefits
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here’s what makes us unique
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model—offering full-service, functional service provider, and consulting—enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
Top Skills
What We Do
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of Full-service CRO, FSP, and Resourcing solutions guided by compassion, care, and excellence.
Founded in 2014 and headquartered in Paris, France, and operating in 28 countries across Europe, USA and India, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas, with speciality focus on Oncology & Hematology, Rare Disease & Pediatrics, Infectious Disease, Inflammation & Immunotherapy, Pain Treatment & CNS, and Late Phase & RWE.
