Clinical Monitor Lead

Description de l'emploi

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.

What we offer:

  • 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
  • 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
  • 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.
  • Validate the final clinical study documents
  • 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).
  • Coordinate and manage the CRO relationship
  • Co-monitor clinical studies according to the oversight monitoring plan, ensuring adequate contact with investigator sites, identifying and solving issues in study progress, verifying data in-house or by conducting co-monitoring visits, in collaboration with other study team members, and following up as required with CRAs/investigator. 
  • Participate in the ongoing clinical study data reviews in collaboration with the other study team members.
  • Make appropriate and timely reporting in CTMS
  • Ensure the agreed timelines for data collection (CRF/eCRF) and data clarifications/queries are met, sending information to data-management and monitoring CROs as appropriate.
  • Maintain and review key documents required for Clinical Study Report
  • Participate in TMF quality check review regularly to ensure adequate completion during the study course with a final thorough review at the end of the trial prior to study archiving
  • Participate in the preparation and follow-up of any other study systems (such as IWRS/IMP forecasting/ flow etc…), as required.
  • As appropriate, participate in the preparation of study documents and perform site visits prior to audits /inspection and assist in audit follow-up /findings resolution.
  • Assist with the financial follow-up of the study, as required.

Minimum Requirements :

You have a scientific degree (minimum Bac +5), completed by a specific Clinical Research Associate training.

You have an experience in preparing clinical study documentation for study set up, maintenance and closing, in managing and developing relationships with Contract Research Organizations (CROs).

You have a first experience as a Field CRA monitor at least for 5 years

You have a good Knowledge of Good Clinical Practice (GCP), ICH regulations.

You have a team spirit, good interpersonal skills and are autonomous.

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