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Clinical Technical Specialist (EU) (12 month fixed term contract)

Location: home or office based but should be near a major EU travel hub

During this assignment, you will assist in the qualification and set up of sites, training, and initial monitoring of clinical laboratory study staff at Sites participating in a global, drug registration study. This study is being conducted in collaboration with a major pharmaceutical company. The drug registration study will utilize a molecular diagnostic test for a certain type of leukemia developed by Cepheid to monitor the drug response of study subjects. It is anticipated that 100-150 sites will participate in this study.

Responsibilities:
- Assist in the pre-study development of study protocols, investigator manuals, and Site-specific instruction manuals.
- Complete supervised, hands-on training on the use, operation, and troubleshooting of Cepheid's diagnostic instrumentation and leukemia test.
- Be responsible for diverse activities involved in clinical trial set-up, including clinical Site qualification, study initiation visits, and training of on-Site personnel.
- Assist in the transition of study Site monitoring to a contract Clinical Research Organization (CRO).
- Be responsible for timely identification of problems or issues at clinical study Sites that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.


Job Package

Competitive salary will be paid and this will be flexible subject to experience

Person Profile

- Bachelor's or Master's degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry, Biotechnology and/or Human Physiology), or equivalent.

- Minimum of 1-2 years full-time experience in bench research at an academic research laboratory, pharmaceutical/biotech Company, or a hospital including hands on experience with biological specimen collection, handling, and shipping.

- Minimum of 1 year, full-time, clinical research associate (CRA) experience in medical device studies, including an understanding of current regulatory and clinical requirements for diagnostic products.

- molecular diagnostics assays or instrumentation is a must have

- Excellent team working and communication skills required.

- Location is flexible as there will be extensive domestic and international travel (50-75% of time) and therefore proximity to major, European airport is preferred.

- This is either an office or home-based position

- Need to be fluent in English plus at least one other European language would be an advantage


Interview Process

Telephone screening and face to face interview

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Cepheid
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£ competitive
UK & EU
Job Ref: 46394

Liam Whelan

Executive Recruiter

liam@zenopa.com +44 1494 818 027

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