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Clinical Project LeaderRef: DT24154

Salary:€95000 - €100000 per annum

Added:15 May 2019

Region: Europe

Sector: Pharmaceutical

Sub Sector: Clinical Research

RESPONSIBILITIES: The research and new technology group is responsible for the design, management and evaluation of regulatory submission and post-marketing trials as well as investigator initiated studies. We are currently looking for an experienced clinical project leader who will take over the full responsibility of a strategic regulatory approval project and clinical trial. *Project management responsibility for a clinical project targeting an FDA premarket approval (PMA) of a strategic and innovative medical device product *Conduction and oversight of a multi-center (Europe and US) randomized controlled trial within planned timeline and budget *Management of a CRO *Definition and co-authoring all essential clinical study documentation as required by the FDA and local legal requirements (ethical committees and IRBs) *Keeping a close contact with clinical investigators and sites in Europe and US, regularly visiting them (substantial amount of business travel time) *Support and review of draft publications for peer reviewed journals *Willingness to travel up to 50% of your working time QUALIFICATIONS: *Master or bachelor`s degree in science or medicine *At least 10 years of clinical trial experience within the medical device industry and at least 5 years in the role of a clinical project leader *Proven successful completion of clinical trial(s) designed to obtain FDA approval of a medical device (e.g. Class III device) *Experience in working with and managing CROs *Experience in international medical device regulations; relevant guidelines-knowledge of FDA PMA *Experience in communicating with regulatory authorities, specifically FDA is a must *Fluency in English language is required, any additional language is an advantage These qualifications would give you an advantage: *Advanced degree (MD or PhD) *Any critical care medicine and clinical environment experience *Knowledge of MDR

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