Clinical Logistic Support Manager – France

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:

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.

 Set-up :
• 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
• Organizes and leads the KO meeting with the CRO, reviews the KO meeting minutes written by the CRO, coordinate the internal stakeholders review and compile the comments
• Develops specifications document in collaboration with the CRO and internal stakeholders, based on the clinical study protocol or synopsis
• Reviews the user documentation with the CRO and internal stakeholders
• Organizes UAT and prepares the UAT plan, the script tests and the pre-requisites (if applicable)
• Collects and provides site and sponsor contact details to the CRO (for material shipment, user account management…)
• Participates to the international monitors meetings to CRAs and PMs, presents procedures to conduct the study for each centralized activity
• Controls the respect of the study timelines, answers to the questions issued by the CRO all along the implementation phase
• Gives the go for Study after checking that all the pre-requisites are fulfilled

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
• Communicates any relevant information (alerts, monthly report) regarding centralized services to other internal stakeholders
• Ensures an operational support for the local teams for CRO related problems in centers, follow-up of CRO related problems in centres, discusses (if needed) with the CRO the action plan to be settled to resolve problems, alerts other local teams (if relevant)
• Ensures the follow-up of budget for centralized services and ensures support for invoices management for internal contract & budget assistants
• 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
• Follows-up on audit action plan

Study end :
• Ensures the centers clean-up (sending back-up samples, recovery/destruction of remaining material, check all images are recovered and read, device recovery, …)
• Ensures the balance of budget of centralized services and ensures support for closure invoices management for internal contract & budget assistants
• Ensures the filling of the Sponsor Study File
• Participates to the CRO evaluation meeting and give a feedback regarding the quality of CRO services performance