Senior Manager, Risk-Based Quality Management
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Pennsylvania • United States
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Job Level
Tech Stack
About the role
- Developing and overseeing clinical risk management strategies, including risk assessment, mitigation planning, and monitoring to ensure the safety and integrity of clinical trials.
- Leading a team in identifying potential risks related to clinical trial operations, data integrity, and patient safety, and implementing effective risk management measures.
- Collaborating with cross-functional teams, including clinical operations, regulatory affairs, and data management, to integrate risk management strategies into overall clinical trial processes.
- Monitoring and analyzing risk-related data and trends, providing insights and recommendations to senior management to address potential issues and enhance risk management practices.
- Ensuring compliance with regulatory standards and industry best practices for risk management, including adherence to Good Clinical Practice (GCP) and other relevant guidelines.
Requirements
- Degree in Life Sciences, Medicine, Risk Management, or a related field.
- Extensive experience in clinical risk management or related roles, with a strong background in assessing and mitigating risks in clinical trials.
- Proven leadership skills, with experience managing and developing a team focused on risk management and patient safety.
- Expertise in regulatory requirements, industry standards, and risk management methodologies, with a solid understanding of clinical trial operations.
- Excellent analytical and problem-solving skills, with the ability to provide strategic recommendations and effectively communicate risk-related insights to stakeholders.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
risk assessmentmitigation planningdata integrityclinical trial operationsregulatory requirementsrisk management methodologiesanalytical skillsproblem-solving skillsGood Clinical Practice (GCP)
Soft Skills
leadership skillsteam managementcommunication skillscollaborationstrategic recommendations