Bioanalytical Study Manager H/F - 95

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.
- Monitor outsourced regulated bioanalytical studies to ensure scientific integrity and compliance with GLP/GCP/ICH standards.
- Review and approve bioanalytical study documents (protocols, validation reports, sample analysis plans, final reports).
- Provide scientific oversight on LC-MS/MS methods for small molecule quantification.
- Evaluate and validate bioanalytical data for accuracy, precision, and robustness.
- Troubleshoot analytical issues and support CROs with technical guidance.
- Perform or supervise non-compartmental pharmacokinetic (NCA) analyses and interpret PK data.
- Ensure CRO performance and compliance through monitoring and documentation reviews.
- Act as primary liaison between internal stakeholders (Clinical, Non-clinical, Regulatory, QA) and external partners (CROs).
- Present bioanalytical and PK results in internal meetings and regulatory submissions.
- Maintain high-quality documentation aligned with internal SOPs and regulatory requirements.