Posted to MedZilla on 11/24/2017


ProClinical

Belgium, Clinical Trial Regulatory Leader - Senior RA_PD_13544-MZ


 
 

Here is a chance to join one of the most globally known pharmaceutical organisations, who is looking to hire a Clinical Trial Regulatory Leader based in Beerse, Antwerp. This job will be working a top 10 pharmaceutical company that works across a range of industries from medical devices to pharmaceutical and consumer goods, operating in over 60 countries.

Job Overview:

The Clinical Registry is responsible for posting accurate, validated and consistent information about our trials and their results on about 40 registries globally. The CR directly maintains clinicaltrials.gov and posts results on EudraCT. The CR oversees and supports all other regional or country specific registries. The CR is the centre of expertise for disclosure requirements and ensures data quality and compliance requirements for all registries are met. The CR is based in the company BRQC, but supports all pharma, consumer and medical devices operating companies that have studies with disclosure requirements. We work closely together will clinical and medical teams, clinical development operations, regulatory affairs, bio stats, programming, and local operating companies to ensure the company meets its disclosure requirements. Through collaboration with other BRQC departments and IT we ensure complete and high-quality data is available for timely disclosure of all required studies. The CR team is in the US and EU and part of the work is performed in an offshore model in India. Because of expansion of our scope and growth of the trial portfolio, we are recruiting for an additional clinical registry senior specialist, international registries.

Job Responsibilities:

  • Understand the global clinical registry landscape and customer needs for protocol and/or results disclosure
  • Keep abreast of and document changing regulatory disclosure requirements for the assigned countries.
  • Perform impact assessment and document required changes to the Clinical Registry Repository Content
  • Partner with relevant Local Operating Company personnel to:
  • Maintain up to date disclosure requirements for the country
  • Obtain a correct interpretation of the local disclosure requirements
  • Create a country specific disclosure agreement if appropriate, including processes to support adherence to the local registry requirements.
  • Ensure timely availability of approved registry data to ensure on time, accurate and consistent clinical data disclosure.
  • Maintain up to date registration and disclosure intelligence (i.e. regulatory intelligence, registry intelligence,) in the International Clinical Registry Repository,

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 Peter Duvall on +44 203 0789 542 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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