Established in 2014, Excelya is a ‘people centered’ contract research organization (CRO).
We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop-shop service model – leveraging a full-service, functional service provider and consultancy – allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique project.
Management of set-up, follow-up and closure of centralized activities with Contract Research Organizations (CROs) during clinical trials. The centralized activities are related to: biological samplings for analysis, central reading, interactive randomization systems (IRS), electronic clinical data acquisition (ePRO, connected objects), questionnaires and material, services to the patients.
- Participates to the study launch meeting
- Organizes and leads the internal evaluation committee (go/no go meeting for each planned centralized activity)
- Writes the scope of work/request for proposal with the internal stakeholders and provides final SoW/RFP to Purchase
- Defines the work schedule, ensures the respect of timelines by the Central Services CRO and the internal stakeholders, alerts in case of any delay
- Estimates the budget
- Participates to the CRO selection (pre-selection, analyses of responses, Bid Defense meetings, final selection)
- Participates to the financial and legal negotiation (if requested)
- Follows-up of contract approval
- Reviews the user documentation with the CRO and internal stakeholders
- Collects and provides site and sponsor contact details to the CRO (for material shipment, user account management…)
- Controls the respect of the study timelines, answers to the questions issued by the CRO all along the implementation phase
Study conduct :
- Ensures the operational follow-up of CRO services by checking the compliance with contractual engagements and the quality of the services
- Participates to the follow-up meetings organized by the Central Services CRO, review and comments the minutes of the follow-up meetings
- Manages the amendments during the study (sends the details of the change request to Purchasing, participates to discussion about cost strategy related to change, agrees on budget with Purchasing, discusses and agrees with the CRO on timelines to implement change, updates SoW if necessary, participates to the review of the contract amendment
- Ensures the balance of budget of centralized services and ensures support for closure invoices management for internal contract & budget assistants