Clinical Project Leader

Key People


Job ID :

14913


Company Type :

Staffing Firms


Industry :

Science and Research


Education Level :

Master of Science


Address 1 :

Western Europe,Switzerland,Chur,


Key Skills :

clinical research, clinical trials, medical devices, respiratory


Salary :

€95000 - €100000 per annum


Date Posted :

15 May, 2019



Company Name :

Key People


Location1 :

Chur




Job Category :

Clinical Research Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

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


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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