Global Clinical Trial Manager – Biotech, Remote

Reason for Need: Growth due to rapidly expanding pipeline, extensive within Oncology where they have 20 molecules in development spanning multiple modalities (small molecules, cell therapies etc.). 

• Leader of the cross-functional Clinical Study Team.  Manage the conduct of clinical trials from study design through to close out at global level, ensuring the quality and scientific integrity of the trial in a Risk-Based Study Execution model Oversight of and close collaboration with study team members as well as cross functional stakeholders, through effective communication and proactive identification of opportunities as well as risks, management and mitigation to ensure timely and on-budget execution of clinical trial deliverables Leading the Clinical Study Team to drive effective decision making. Ensuring the conduct of studies in accordance with Regulatory Authorities, company SOPs and ICH-GCP guidelines including Trial Master File (TMF) Management, ensuring  inspection readiness at all times. Perform risk assessment and develop risk mitigation strategies to support study delivery Effective management of vendors to the required standards Lead/support global process development and improvement activities

Interview Process: 1x telephone interview with HR, followed by a TC with line managers and a video interview to finish with presentation.

Profile/Selling Points:

• Must have strong global, cross-functional study lead experience, Phase II-III a must early phase a bonus. They type of CPM’s that sit as global cross-functional lead on 2-3 large/complex studies.
• Can consider candidates from CRO, Pharma or Biotech.
• The best candidates will have strong Oncology and experience working with adaptive trials
• Candidates must have some experience of running in-house studies
• Will be responsible for 1-2 studies at any one time – very good with work/life balance and have a 37.5 hour week with early finishes on Friday’s
• The GCTM’s will report into a Program Manager