Clinical Trial Assistant 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.About the Job

Excelya is seeking a Clinical Trial Assistant to join our dedicated team in revolutionizing the clinical research landscape. Our core values-Audacity, Care, and Energy-guide our mission to provide innovative solutions that make a difference in patient care and clinical outcomes. As a Clinical Trial Assistant, you will play a pivotal role in support of our clinical trials, helping ensure they run smoothly and efficiently.

Main Responsibilities

- Assist in the execution of clinical studies by supporting clinical project management and coordination efforts.
- Maintain the integrity of the Trial Master File (TMF) by ensuring timely updates and compliance with applicable regulations and guidelines.
- Support site management activities, including preparation and maintenance of essential documents for investigators and regulatory agencies.
- Coordinate the logistics of study materials, ensuring timely distribution and tracking of clinical trial supplies.
- Utilize clinical trial management systems (CTMS) to monitor study progress and update study trackers.
- Help in scheduling meetings, preparing agendas, and documenting action items and minutes.
- Act as a liaison between the study team and clinical sites to facilitate communication and resolve queries efficiently.
- Assist in site initiation and close-out activities, ensuring all necessary documentation is collected and reviewed.
- Support administrative aspects such as budget tracking, contract management, and vendor coordination.
- Ensure compliance with all regulatory requirements and assist in maintaining audit readiness of clinical documentation.

WhyJoinUs?

AtExcelya,wecombinepassionforsciencewithenthusiasmforteamworktoredefineexcellenceinhealthcare.

Here'swhatmakesusunique.

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

Excellingwithcaremeansbenefitingfromanenvironmentthatvaluesyournaturaltalents,pushesboundarieswithaudacity,andnurturesyourpotential,allowingyoutocontributefullytooursharedmission.

About You

To thrive in the Clinical Trial Assistant role at Excelya, we are looking for self-motivated individuals who embody our values and possess the following qualifications:

- Experience: Relevant experience in clinical trials or a related field is a plus, but recent graduates with a keen interest are encouraged to apply.
- Skills: Strong understanding of Good Clinical Practice (GCP) and regulatory requirements. Exceptional organizational and communication skills are essential. Knowledege of Veeva Vault.
- Education: A degree in Life Sciences, Pharmacy, or a related field.
- Languages: Fluency in both French and English is required.