Posted to MedZilla on 5/24/2017


ProClinical

Denmark, Lead Clinical Research Associate, Denmark CR_KG_11993-MZ


 
 

ProClinical is currently recruiting for a Lead Clinical Research Associate on behalf of a leading biopharmaceutical company located in Copenhagen, Denmark. This biotech is dedicated to bringing truly innovative oncology products to the market, creating optimally selected antibody mixtures that address multiple oncology targets in a single drug product. Our client is offering a unique possibility for the Lead Clinical Associate to take part in the clinical development of their antibody products. They are offering the Lead CRA a challenging and versatile job in an innovative, flexible, focused and committed biotech environment and, a compensation package including a personalized and company-wide bonus system, flexible working hours and an inspiring working environment.

Job Role: 

As Lead CRA, you will work in close collaboration with the Clinical Trial Manager (CTM) and the Clinical Trial Team in supervising, monitoring, and supporting the administration and progress of clinical trials. When monitoring is performed by a CRO, you will, in collaboration with the Clinical Trial Team and the CTM ensure oversight of contracted resources. You will also be responsible for the handling, maintaining, and filing of clinical documentation for the Trial Master File and supporting the CTM in the planning, execution, and reporting of the clinical trials and the Some travelling must be expected (approximately 10%).

Skills and Experience:

  • Education: Minimum Bachelor's Degree in Life Sciences, related field, or equivalent job experience. Advanced degree or certification is preferred.
  • Minimum of 5 years' experience as a CRA in a Pharmaceutical/biotech company or CRO environment
  • Clinical Trial Documentation/Good Clinical Practice (GCP) experience
  • Functional knowledge of the clinical development process/GCPs/ICH guidelines
  • Understands applicable U.S. Food & Drug Administration (FDA) and European regulations and requirements
  • Experience in Oncology
  • Experience in training CRO and/or clinical trial site staff
  • Experience from a similar position as Lead CRA
  • Effective communication (verbal and written English) and organizational skills
  • Excellent interpersonal skills, proactive, highly meticulous and attentive to detail
  • Able to work independently in a changing environment

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kristian Gustafsonon +44 203 8569 337 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.



Please visit our website at www.proclinical.com

 
 


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