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Clinical Study Manager

  1. Central Germany
Berlin
  1. Contract
Competitive
  1. CAPEX Projects
20-05-2024
KT003Berlin
 Clinical Study Manager - Pharmaceuticals - Various EU Locations 

We have an exciting opportunity with a North Carolina based client who’s focus on the research, development, and commercialisation of products helps patients who haven’t yet received necessary care. You would contribute to their portfolio of life changing products as a Clinical Study Manager in their newest Europe facilities.


Responsibilities include:
  • 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! 

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