With the exception of independent contractors, applicants for this role will be engaged through Randstad company. When making this application your details will be automatically shared with Randstad company for registration with them, who may also contact you about other opportunities with other clients.


Clinical Development Scientist

Posted Jan 23, 2020
Project ID: PHILJP00021334
Eindhoven , Noord Brabant
6 months
(Apr 15, 2020 - Oct 15, 2020)
40 hrs/week
Payrate range
41 - 60 €/hr

In this role, you have the opportunity to
Ensure that studies (clinical and non-clinical) for product approvals in Mother and Childcare Business unit are appropriately designed throughout the entire product creation and lifecycle to deliver evidence of value

•   Providing support for the operation of clinical trials and product approvals in the USA, EU and ROW;
•   Obtaining approval to conduct clinical trials of investigational equipment;
•   Identifying and preparing clinical trial documentation (Protocol, Investigator Brochure, Consent Form, and Case Report Form) to obtain product approval and reimbursement classification for new products;
•   Developing documentation and obtain Competent Authority approval and Ethics approval for non-CE marked product in the European Union;
•   Developing IDE (Investigational Device Exemption), IRB (Institutional Review Board), 510(k) (Pre- Market Notification), and PMA (Pre-Market Approval) and Panel meeting documentation and receives approval to conduct clinical trial (IDE, IRB) or release device for sale (510(k), PMA);
•   Organizing, executing and submitting results of post marketing surveillance studies as mandated by FDA

Job families:
•   Lead clinical risk assessment throughout – from ideation through LCM
•   Development of evidence generation & dissemination strategies to support all innovation projects
•   Delivery of Clinical Development Plans, describing the plans for clinical evaluation, as per KM requirements (EU, China, etc)
•   Delivery of clinical programs, working in partnership with Clin Ops & BSDM
•   Lead dissemination of clinical evidence
•   Lead clinical scientific discussions with FDA, CAs, NBs, KOLs, Advisory Boards, etc

•   Global Study Management, medical devices and/or life sciences or equivalent;
•   PhD degree or Master’s degree with 3-5 years of experience
•   Experience in clinical trials and development of clinical protocols and investigations;
•    Working knowledge of statistical analytics Working knowledge of FDA and ISO Regulations
•   Global product knowledge;
•   Problem solving skills for regulatory, quality and safety issues;
•   Fluency in English
•   Working from home is a possibility, but we are looking for someone who is available for at least 3 day in the office in Eindhoven (High Tech Campus)

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