Clinical Risk Lead

1 hour, 57 minutes ago
Full-time
Mid Level
Project and Program Management
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

Description

  • Coordinate initial risk assessments during the request for proposal and bid-defense stages with key stakeholders.
  • Lead cross-functional teams in identifying critical variables, study-specific risks, and key risk indicators after study award.
  • Create, maintain, and update project-specific Risk Management Plans and related project plans.
  • Coordinate development and periodic review of project-specific QTLs and Integrated Strategic Monitoring Plans (ISMPs).
  • Work with the study team to develop monitoring plans, including on-site, central, and remote monitoring approaches.
  • Communicate risk identification, escalation, mitigation strategies, and corrective/preventive actions across the study team.
  • Conduct periodic reviews of identified risks and update plans based on new or revised risk assessments.
  • Develop and deliver training on risk assessment, centralized monitoring, and risk-based monitoring strategy.
  • Provide subject matter expertise, coaching, and protocol review support to cross-functional teams.
  • Participate in process improvement initiatives and ongoing refinement of the risk management process.

Requirements

  • Undergraduate degree required.
  • 4-6 years of relevant experience, including at least 3 years in clinical trials.
  • Knowledge and prior experience with Risk-Based Quality Management (RBQM) concepts.
  • Proficiency with MS Office.
  • Strong written and verbal communication skills.
  • Highly effective interpersonal and organizational skills.
  • Demonstrated proactive, detail-oriented, critical thinking, and task-driven approach.
  • Ability to work effectively in a global and cross-functional environment.
  • Working knowledge of GCPs and local regulations.
  • Ability to apply a risk management approach to identifying and mitigating trial risks.

Benefits

  • Home-based working arrangement.
  • Full-time, permanent role.
  • Annual salary of €52,000 - €86,500.
  • Bonus opportunity.

Interested in this position?

Apply directly on the company website

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