Clinical Operations Lead

Excelya Group; Paris; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

A leading mid-size CRO based in France is seeking a Clinical Operations professional with a minimum of 5 years of experience in clinical monitoring and study management. The ideal candidate will lead operational aspects of clinical studies, ensuring compliance and effective communication between teams and sites. Proficiency in CTMS and EDC systems is essential, along with strong leadership and interpersonal skills. This role offers an enriching environment for personal and professional growth.

Qualifications

• Minimum of 5 years of experience in clinical monitoring and study management.
• Prior experience as a CRA or in a lead role is highly desirable.
• Bilingual in French, proficient in English.

Responsabilités

• Lead and coordinate operational aspects of clinical studies.
• Liaise between project teams and clinical sites.
• Plan and execute monitoring visits, including reports.
• Train and mentor Clinical Research Associates (CRAs).
• Review study-related documents for accuracy.
• Manage study budgets and timelines.
• Ensure site staff are knowledgeable about protocols.
• Facilitate problem-solving and risk assessment.

Connaissances

Clinical monitoring

Study management

Leadership

Communication

Interpersonal skills

GCP understanding

CTMS proficiency

EDC systems knowledge

Formation

Bachelor’s degree in life sciences, medicine, or a related field

Description du poste

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

• Lead and coordinate the operational aspects of assigned clinical studies, including study start-up, site management, and monitoring activities to ensure compliance with protocols and GCP standards.
• Act as the primary liaison between project teams and clinical sites, ensuring effective communication and collaboration.
• Oversee the planning and execution of monitoring visits, including preparation of visit reports and follow-up on findings.
• Train and mentor Clinical Research Associates (CRAs) and ensure they are aligned with project goals and objectives.
• Review study-related documents for accuracy and completeness, ensuring regulatory compliance throughout the study lifecycle.
• Support the management of study budgets and timelines, providing regular updates to project stakeholders.
• Ensure that site staff are knowledgeable about study protocols and GCP requirements through ongoing training and support.
• Facilitate problem-solving and risk assessment to address issues that may arise during the study.

About You

• Experience: Minimum of 5 years of experience in clinical monitoring and study management within a CRO or pharmaceutical company; prior experience as a CRA or in a lead role is highly desirable.
• Skills: Strong understanding of GCP, ICH guidelines, and regulatory requirements; excellent leadership, communication, and interpersonal skills; proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Education: Bachelor’s degree in life sciences, medicine, or a related field; advanced degree is a plus.
• Languages: Bilingual in French, proficient in English; knowledge of additional languages is an advantage.

WhyJoinUs?

AtExcelya,wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare.

Here'swhatmakesusunique—

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

Excellingwithcare

meansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential,allowingyoutocontributefullytooursharedmission.