Job Description
The primary responsibility of the Global Feasibility Associate is the organization and coordination of site feasibilities for all multicenter Phase II-IV clinical trial projects.
Your tasks
1. Analyse and Assess Request for ProposalReview the RFP and the included study descriptionReview the protocol for specific informationPrepare blinded synopsis from protocol a feasibility plan in consultation with the Global feasibility managerPrepare project-specific feasibility questionnairePrepare message text for the specific project and target population
2. Execute FeasibilityParticipate in Kick-off meeting(s)Support the development of the feasibility planIdentify the persons/sites to be contacted
3. Collect InformationSend out blinded synopsis or feasibility questionnaire to the pre-specified sitesFollow-up on answers received or outstanding responseEnter the feedback into the database
4. Write Feasibility Outcome Report/ Feasibility Preliminary AssessmentDraft a feasibility outcome or preliminary assessment reportConsult with clinical project managers regarding the proposal, including the country split and patient target per country.Finalise the report and distribute internally
5. Ad hoc requests:Assist in preparing PPT slides for bid defense when requiredIdentify potential sites for placing trials, assess their interest for close collaboration and conclude with contract.
You will report to Head of Feasibility.
Qualifications
6. University degree (equal to 4 years of college) in (para-)medical, pharmaceutical, sciences, life-sciences or biosciences. Equally recognised degrees and/or relevant qualifications by experience may also be acceptable and assessed on a case-by-case basis.
7. A basic to intermediate understanding of clinical trials and key elements of a trial protocol.
8. At least 1 year of experience in clinical trial conduct or management (phase I-III) at the site, CRO, or sponsor level would be preferred.
9. Knowledge of EU CTR and ICH-GCP and, if applicable, of FDA CFR 21
10. Professional : you bring quality, excellence, and ownership to everything you do
11. Responsible and results-oriented : you have a sense of accountability for business results
12. Committed : you bring your whole self to work with passion and focus
13. Driven and eager : you are curious, flexible, and ambitious to learn from a global network
14. Open to learning : from the range of different skills, backgrounds, and behaviors around you
15. Capable of taking ownership and being independent
16. Ambitious : you always challenge yourself to continuously improve and be the best you can be