Senior Operational Compliance Associate at ICON ensuring operational compliance with regulations and organizational policies in clinical research. Collaborating with teams to promote quality and integrity across operations.
Responsibilities
Monitoring and auditing operational processes to ensure compliance with applicable regulations, guidelines, and company policies.
Conducting risk assessments and compliance reviews, identifying areas for improvement, and recommending solutions to mitigate compliance risks.
Collaborating with project teams to develop and implement compliance training programs and resources, fostering awareness and understanding of compliance requirements.
Providing expert guidance on compliance issues, supporting operational teams in understanding and adhering to regulatory requirements.
Participating in the development and maintenance of standard operating procedures (SOPs) related to operational compliance.
Assisting in preparing for regulatory inspections and audits, ensuring that all documentation and processes are in compliance.
Staying updated on industry regulations, guidelines, and best practices to ensure ongoing compliance within the organization.
Reporting compliance findings and metrics to senior management, highlighting trends and recommending corrective actions as needed.
Requirements
Bachelor’s degree in life sciences, healthcare, or a related field.
Advanced degree or certification in regulatory affairs or compliance is preferred.
Extensive experience in operational compliance or quality assurance within the clinical research industry.
Strong understanding of regulatory requirements, guidelines, and best practices related to clinical trials and operational processes.
Excellent analytical and problem-solving skills, with the ability to assess complex compliance issues and develop effective solutions.
Strong communication and interpersonal skills, with the ability to influence and collaborate effectively with diverse teams.
Proficiency in compliance management systems and tools, as well as experience in auditing and monitoring practices.
Detail-oriented with strong organizational skills, capable of managing multiple projects and priorities simultaneously.
Commitment to maintaining high standards of quality, compliance, and ethical practices in all operational activities.
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.
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