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Senior Clinical Trials Manager

  1. Dublin
County Dublin
  1. Permanent
Competitive
  1. CAPEX Projects
22-04-2024
KT002
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Senior Clinical Trials 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 Senior Clinical Trials Manager in their newest Europe facilities. 


Requirements
  • Independently manage all components of a clinical trial, leading a cross-functional study team. The assigned clinical trial may be of high complexity or high risk.
  • Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Kyverna SOPs.
  • Participate in the identification, evaluation, selection, and oversight of clinical trial sites in collaboration with the Clinical Research Organization (CRO)
  • Partner efficiently, effectively, and professionally with participating study sites to ensure smooth study conduct.
  • Implement strategic operational activities to ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites.
  • Review invoices and track study budget according to the forecast, working closely with finance and clinical business operations.
  • Manage external vendors with oversight of activities.
  • Oversee implementation and maintenance of Trial Master File for inspection readiness.
  • Develop study documents and tools including study, informed consent forms, project plans, budgets, study logs, templates, and other materials as needed.
  • Collaborate with clinical team and vendors to develop study-specific documents, and maintenance of internal files
  • Provide study status updates and reports to senior management.
  • Participate in ongoing study data reviews and data cleaning activities.

Responsibilities
  • Established Cell Therapy /CAR T study experience required.
  • B.S. degree with minimum 7+ years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
  • Strong clinical study conduct experience from start-up through close-out, with global trial and CRO management experience highly preferred.
  • Strong leadership, effective decision making, and problem-solving skills required.
  • Established knowledge of clinical operations.
  • Working knowledge of relevant GCPs and FDA/EMA regulations.
  • Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
  • Excellent written and verbal communication skills.

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

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