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Senior Manager, Clinical Compliance
ICON plcSenior Manager, Quality Assurance ensuring compliance with regulatory standards in clinical trials at ICON. Leading quality assurance activities and team management to support innovative treatments.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage quality assurance and compliance activities across your area, ensuring your team delivers to the highest standards
- Develop and implement quality assurance strategies and processes to support clinical trial activities
- Conduct comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines
- Collaborate with cross-functional teams to identify and address quality issues and implement corrective actions as needed
- Participate in the review and approval of clinical trial documentation and data to ensure accuracy and completeness
- Provide leadership and mentorship to quality assurance staff, fostering a culture of excellence and continuous improvement
Requirements
What you’ll need- Bachelor's degree in a relevant discipline
- Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a management or leadership role
- Strong knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations)
- Excellent analytical and problem-solving skills, with the ability to identify and resolve complex quality issues
- Exceptional communication and interpersonal skills, with the ability to collaborate effectively with colleagues and stakeholders at all levels
- Willingness to travel as required (approximately 35%)
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancecompliance activitiesquality assessmentsauditsquality assurance strategiesclinical trial documentationdata accuracycorrective actionsregulatory standardsregulatory requirements
Soft Skills
leadershipmentorshipanalytical skillsproblem-solving skillscommunication skillsinterpersonal skillscollaborationcontinuous improvementteam managementstakeholder engagement