Clinical Monitoring Lead Oncology H/F - Excelya

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

- Ensure the operational delivery of clinical studies from feasibility to site closure, in compliance with GCP, protocols, timelines, budgets, and allocated resources
- Act as the main operational interface between Clinical Research Associates (CRAs), investigators, and global clinical and medical teams
- Contribute to the preparation, review, and validation of study documents (protocols, ICF, CRF, etc.)
- Coordinate financial aspects of clinical studies (vendors, contracts, budgets, invoicing)
- Oversee CRA activities and provide scientific and technical support throughout the studies
- Prepare and manage regulatory and administrative submission files in collaboration with CRO partners
- Ensure study quality and scientific alignment, propose and implement corrective and preventive actions when needed
- Support audits and inspections and contribute to continuous improvement initiatives
- Organize and coordinate investigator meetings and investigator training sessions
- Oversee pharmacovigilance activities and IMP management for assigned studies

WhyJoinUs?

AtExcelya,wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare.

Here'swhatmakesusunique-

Weareayoung,ambitioushealthcompanyrepresenting900Excelyates,driventobecomeEurope'sleadingmid-sizeCROwiththebestemployeeexperience.Ourone-stopproviderservicemodel-offeringfull-service,functionalserviceprovider,andconsulting-enablesyoutoevolvethroughdiverseprojects.Workingalongsidepreeminentexperts,youwillhelpimprovescientific,operational,andhumanknowledgetoenhancethepatient'sjourney.

Excellingwithcaremeansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential,allowingyoutocontributefullytooursharedmission.

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:Operational experience in the pharmaceutical industry or a CRO (excluding internships and short-term missions), Proven experience in oncology clinical trials (Phases I preferred; II-III a plus).
- Skills:Strong knowledge of GCP and clinical research regulations, Ability to manage multiple projects in parallel and adapt to changing priorities.
- Education:Degree in Pharmacy, Engineering, Life Sciences (Bachelor's or Master's level or equivalent)
- Languages:French & English mandatory