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Clinical Risk Lead

16 hours, 27 minutes ago
United Kingdom
Full-time
Senior
Project Manager
Quality Assurance and Testing
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 36

Description

  • Oversee risk management activities across a portfolio of clinical projects in line with ICH GCP E6 requirements.
  • Coordinate the development of project-specific risk assessments, Risk Management Plans, and Integrated Strategic Monitoring Plans during study start-up.
  • Drive compliance with risk management plans throughout the full project lifecycle.
  • Maintain the risk library and promote consistent risk assessment and management practices across the organization.
  • Assist in developing the clinical monitoring strategy and applying RBQM principles to functional plans with other leads.
  • Coordinate and conduct initial risk assessments during request for proposal and bid-defense stages with cross-functional stakeholders.
  • Lead cross-functional teams in identifying critical variables, study-specific risks, key risk indicators, and quality tolerance limits.
  • Work with data management and the project team to build and review project-specific QTLs and project plans, including on-site, central, and remote monitoring plans.
  • Develop, recommend, and track risk mitigation strategies, including issue escalation, root cause analysis, and corrective/preventive actions.
  • Deliver training, coaching, and SME support to study teams, and contribute to process improvement and ongoing review of the risk management process.

Requirements

  • Undergraduate degree is required.
  • 4-6 years of relevant experience is required.
  • At least 3 years of experience in clinical trials is required.
  • Knowledge and prior experience with Risk Based Quality Management concepts is required.
  • Proficiency with MS Office is required.
  • Strong written and verbal communication skills are required.
  • Highly effective interpersonal and organizational skills are required.
  • Ability to work in a global environment and cross-functional team is required.
  • Understanding of GCPs and local regulations is required.
  • Experience in clinical monitoring strategy, risk management systems, or related trial oversight activities is preferred.

Benefits

  • £37,000 - £61,500 annual salary.
  • Bonus opportunity.
  • Home-based / remote working arrangement.
  • Accommodation for job applicants with disabilities available upon request.

Interested in this position?

Apply directly on the company website

Apply Now

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