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Clinical Study Manager

  1. London
Dublin
  1. Permanent
Competitive
  1. Life Sciences
15-04-2024
27105
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Clinical Study Manager - Pharmaceuticals - London, UK 

Do you relish the opportunity to work with a global biotech organisation based in the UK? If yes, then this is the assignment for you!

Our client that specialises in the treatment and prevention of serious human medical conditions is currently seeking the expertise of a Clinical Study Manager. 


Responsibilities: 
  • Clinical project management of a clinical study
  • Create and drive study level timeline
  • Develop overall feasibility concept and enrolment plan with input from COMs
  • Develop and manage study budget
  • Provide input on operational aspects of the protocol
  • Ensure regulatory compliance and GCP compliance
  • Responsible for oversight of TMF with periodic audits
  • Responsible for/contribute to vendor selection and management including issue escalation
  • Develop and manage Study Management plan and all associated documents (i.e. vendor oversight plan)
  • Collaborate with CS&L team to plan and coordinate IMP and non-IMP supplies
  • Plan facilitate and lead SET internal meetings as well as act as the CSL lead for vendor meetings
  • Ensure monitoring plan is developed and consistently executed in collaboration with COMs
  • Contribute to development of proactive strategy and corrective action plan to address study issues in collaboration with SET and COMs
  • Assigns and documents study specific roles and responsibilities to internal and external team members
Qualifications, Skills and Experience:

  • Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
  • Other degrees and certifications considered if commensurate with related clinical research experience (e.g. diploma or associate degree RN, certified medical technologist).
  •  Desirable:
  • Postgraduate qualifications.
  • Experience in scientific/medical research.
  • Specialist knowledge (e.g. vaccine and/or influenza).

If this role is of interest to you, please apply now! 

 #LI-KT1

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