Clinical Drug Delivery Device Lead

Il y a 2 mois


Brainel'Alleud, Belgique amaris Temps plein

Job description
We are seeking a methodical, detail-oriented Clinical Drug Delivery Device Lead with excellent interpersonal skills to join our Devices, Artwork, and Packaging team. This position can be based at one of our campuses in Braine l’Alleud, BE, Slough, UK, or Bulle, CH.
About the Role
This role focuses on providing support in the selection and/or assessment of drug delivery devices used in sponsored clinical trials.
Who You’ll Work With
What You’ll Do
Define and implement the overall strategy for various drug delivery devices to be used in clinical trials.
Collaborate with a cross-functional team (including clinical, QA, RA, safety, and SME teams) to ensure timely support for clinical trials.
Lead the Clinical Drug Delivery Devices sub-teams to ensure appropriate selection and assessment of drug delivery devices for clinical trials.
Perform technical assessments for devices used in clinical trials and selected by our CROs.
Interested? For This Role, We’re Looking for the Following Education, Experience, and Skills
A master’s degree with a relevant academic background, ideally a nurse or a physician.
8+ years of experience in clinical drug delivery devices selection.
Extensive knowledge of medical devices and pharmaceutical environments.
Experience in clinical trials setup.
Understanding of the issues and challenges of selecting appropriate and fit-for-purpose devices from FIH to Phase 4 clinical trials studies.
Thorough knowledge and understanding of Medical Devices Regulations (EU MDR, 21CFR part 820, ISO13485) and GxP (GMP and GCP).
Experience in drug-device compatibility testing and material contact assessment is a plus.
Project management skills.
Ability to lead and influence cross-functional and matrix teams.
Excellent writing skills.
Autonomous and detail-oriented.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7500 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities
**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
We look forward to meeting you



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