Clinical Operations Lead Neurology H/F Excelya

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.