Clinical Research Associate in ATU

Excelya>Full-time>Clinical Research Associate in ATU

Job description

Founded in 2014, Excelya is a 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 provider 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.

 

Mission:

Temporary Use Authorizations (TUAs)

Implementation of Trackers for the follow-up of Temporary Use Authorizations
Management of requests for access to treatment (ATU): creation of files, verification of the ATU, creation of Physicians and Pharmacists profiles, input on the platform, transmission to the medical team for approval, information to the Physicians of the approval or refusal
Telephone switchboard to meet the needs of physicians and pharmacists
Management of purchase orders: verification of their conformity, validation, transmission to the customer service
Management of follow-up forms (dose titration, follow-up and discontinuation): verification and entry
Management of pharmacovigilance cases followed in a tracker
Management of the transition to Post-ATU: information to the centers, transmission of order forms to the customer service
Monthly sending of ATU file (stock forecast) and sending of ATU patients number follow-up

Compassionate access

Management of requests: receipt of documents (Order Form, ANSM Authorization and Pre-Approval Access Physician Request and Declaration), checking their conformity, transmitting them to Global for approval, responding to additional requests
Order management: smartsheet file (PRD, ANSM Authorization, Country Release Form, PRD and Patient Release Form (PRF)
Setting up and updating the Tracker
Management of some compassionate access requests for other indications

 

Transversal activities

Pharmacovigilance: follow-up of PV cases, transmission to PV, clarification requests to physicians, weekly meeting with PV
Tickets: creation of tickets for ATU, follow up until resolution
Statistics: manual update of ATU data and update/creation of graphs for reporting to ANSM.
Participation in meetings, and writing of the ANSM report of ATU (nominative ATU and cohort)
Archiving of interventional and non-interventional study contracts

Skills and experience

  • 7/8 year’s minimum work experience as a Talent Acquisition Expert in fast pace and growth environment (with an experience within Search Firm or Consulting company/department) in a matrix structure.
  • Understanding of full cycle recruiting and employer branding initiatives
  • Excellent communication skills with the ability to foster long-term relationships (with internal teams, external partners and candidates) and team management experience
  • Understanding of sourcing techniques & tools, ATS reporting experience
  • Good level of English both spoken and written.
  • Proactivity, sense of initiative, flexibility, strong sense of service and team spirit
  • Solution finder (strategic thinking with strong hands-on capacity)
  • MSc in Human Resources Management or relevant field

Summary

Contact

Apply for this job

Similar career opportunities