Clinical Operations Lead - Aesthetics Medicine H/F - 75

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 our values Energy, Care and Audacity.

Founded in 2014 and headquartered in Paris, France, 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.

We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.

Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.AbouttheJob

JoinExcelya,whereAudacity,Care,andEnergydefinewhoweareandhowwework.Webelieveincreatingboldsolutionsandfosteringaninclusiveenvironmentwherecollaborationandindividualgrowthgohandinhand.

Thisroleisanexcitingopportunitytocontributetoadynamic,ambitiousteam.Youwillplayacriticalpartindrivinginnovationandmakinganimpactintheclinicalresearchspace,whileenjoyingastimulatingprofessionalenvironmentthatencouragespersonalandintellectualgrowth.

Main Responsibilities

- Supervise the Clinical team of CROs to ensure an efficient study start-up.
- Monitor the collection and submission of essential regulatory and ethics documents.
- Ensure CRO completion of EDC tasks within defined timelines.
- Train CRAs on study-specific activities and organize investigator/monitor meetings.
- Establish detailed project milestones in collaboration with the study team.
- Draft and validate key clinical oversight documents (manuals, monitoring plans, etc.).
- Review and follow up on site visit reports to address identified issues.
- Coordinate and manage the CRO relationship while supporting internal CRAs when needed.
- Perform co-monitoring visits to ensure study quality and resolve site-related issues.
- Track and report study data (CTMS), review TMF, and assist in audit preparation.