Clinical Trial Manager
Excelya
Paris
I. Excelya
Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial, and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
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Responsibilities :
Ensure efficient and thorough study start-up by overseeing the Clinical team of the CROs and working closely with other relevant team members involved in the study set up (DM, Reg, CMC etc…): to verify timely collection of essential study documents, such as regulatory and ethics committee documents for submission, and by controlling that all set up activities are performed prior to each site initiation.
II. Description
Support and ensure that all specific CRO EDC system tasks under the clinical responsibility are completed and achieved according to the defined timelines without jeopardising the start of a trial.
Support the Clinical CRO in the training of the CRAs on all study specific operational activities and participate in the organisation and preparation of the monitor and investigator meetings in collaboration with the other study team members (Corporate and/or affiliates, CROs as appropriate)
Assist the GCPM/ study team in the evaluation of detailed timelines and establishment of clinical studies milestones for assigned projects, ensuring that they are performed to the most rigorous standards of quality and timely delivery.
Prepare and/or assist in the production of all documents necessary to oversee the clinical activity implementation, monitoring and reporting in a professional, high quality and timely manner (such as monitoring oversight plan…).
Validate the final clinical study documents (such as study manual, monitoring plan …) prepared by the Clinical CRO.
Review all/a sample of site visit reports as per the Oversight Monitoring Plan ensuring timely and appropriate follow up of issues raised by monitors (Corporate & affiliates and/or CROs as appropriate).
III. Profile
- Experience of minimum 2 years of Lead CRA
- Experience as a field CRA Monitor at least 2-3 years
- Excellent Knowledge of Good Clinical Practice (GCP), ICH regulations.