Clinical Study Associate - Biotech - UK

Working within pain management therapies, this role will have involvement in a yet-to-be initiated clinical study set to run across 4 or 5 European companies. You will be integral in supporting the Clinical Team as the study gets underway over the coming year.

 

Responsibilities:

  • Prepare, archive and maintain essential documentation according to SOPs;
  • Management and maintenance of the Trial Master File according to appropriate regulations; 
  • Provide logistic support for study supplies to sites;
  • Prepare relevant documents for Study Drug Approval and release;
  • Collaborate with preparation of required documents for submission to IRBs/ IECs and CA.

 

Requirements:

  • Relevant Life Sciences degree;
  • +3 years' experience working as a Clinical Trial Administrator;
  • Extensive experience in TMF management including set-up and/or maintenance is essential;
  • Good knowledge of requirements regarding essential documentation and GDP;
  • Knowledge of ICH-GCP guidelines and clinical research regulatory environment.

 

This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be.

 

To make an application please feel free to apply via this website, I am also available on LinkedIn to message regarding the role and will accept all invitations that refer to this advert - look for Dominic Mitchell at RBW Consulting.

 

Please note that owing to the high volume of applications we receive for our roles, if you have not received a response within 48 working hours, do please consider your application unsuccessful.

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