The primary responsibility of the Global Feasibility Associate is the organization and coordination of site feasibilities for all multicenter Phase IIIV clinical trial projects.
Your tasks
- Analyse and Assess Request for Proposal
- Review the RFP and the included study description
- Review the protocol for specific information
- Prepare blinded synopsis from protocol summary.
- Draft a feasibility plan in consultation with the Global feasibility manager
- Prepare projectspecific feasibility questionnaire
- Prepare message text for the specific project and target population
- Execute Feasibility
- Participate in Kickoff meeting(s)
- Support the development of the feasibility plan
- Identify the persons/sites to be contacted
- Collect Information
- Send out blinded synopsis or feasibility questionnaire to the prespecified sites
- Followup on answers received or outstanding response
- Enter the feedback into the database
- Write Feasibility Outcome Report/ Feasibility Preliminary Assessment
- Draft a feasibility outcome or preliminary assessment report
- Consult with clinical project managers regarding the proposal including the country split and patient target per country.
- Finalise the report and distribute internally
- Ad hoc requests:
- Assist in preparing PPT slides for bid defense when required
- Identify potential sites for placing trials assess their interest for close collaboration and conclude with contract.
You will report to Head of Feasibility.
Qualifications :
- University degree (equal to 4 years of college) in (para)medical pharmaceutical sciences lifesciences or biosciences. Equally recognised degrees and/or relevant qualifications by experience may also be acceptable and assessed on a casebycase basis.
- A basic to intermediate understanding of clinical trials and key elements of a trial protocol.
- At least 1 year of experience in clinical trial conduct or management (phase IIII) at the site CRO or sponsor level would be preferred.
- Knowledge of EU CTR and ICHGCP and if applicable of FDA CFR 21
- Professional: you bring quality excellence and ownership to everything you do
- Responsible and resultsoriented: you have a sense of accountability for business results
- Committed: you bring your whole self to work with passion and focus
- Driven and eager: you are curious flexible and ambitious to learn from a global network
- Open to learning: from the range of different skills backgrounds and behaviors around you
- Capable of taking ownership and being independent
- Ambitious: you always challenge yourself to continuously improve and be the best you can be
Additional Information :
What we can offer you:
- A truly rewarding career working at the highest level of international standards for quality safety and integrity
- The chance to share our growth and stability.
- Continuous learning from the best experts in the industry
- The chance to expand and enrich your career
- Professional and personal growth
- Experiences and opportunities across the global business
Do you want to be part of this
Were you already considering a big switch in your career Maybe this could be your next step. We are looking forward to hearing from you! Send us your story and your resume via the apply button and maybe you will soon join us for work and coffee breaks. Still have questions Anneleen can give you more details about the job. Send her an email at
Remote Work :
No
Employment Type :
Fulltime