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.
Director leading compliance strategies at Walmart, enhancing operational integrity through tech collaboration and team leadership. Fostering partnerships to uphold ethical standards across the organization.
Manager, Field Compliance supporting US Psychiatry compliance program at Lundbeck. Driving and implementing all elements of Lundbeck US Compliance Program along with field - based teams.
Risk & Compliance Lead overseeing compliance management and statutory requirements at JLL. Leading audits and collaborating with cross - functional teams to mitigate legal risks and ensure compliance.
Senior Regulatory Affairs Analyst at Johnson & Johnson, responsible for ensuring compliance and regulatory strategy in São Paulo. Involves preparation and submission of regulatory dossiers and compliance assurance.
Coordinator for regulatory review assisting with product registration and compliance at e.l.f. Beauty, a leader in clean and cruelty - free cosmetics. Collaboration with cross - functional teams for global product launches.
Junior Compliance Manager supporting the development of a compliance management system at an international financial services company based in Cologne, focusing on digital processes and modern governance tools.
Senior Safety & PV Operations Specialist providing support to Safety and Pharmacovigilance. Identifying and maintaining worldwide regulatory requirements and serving as a subject matter expert in pharmacovigilance.
Quality and Regulatory Affairs Manager developing and supporting quality management systems for medical devices. Engaging in regulatory processes and facilitating innovation in healthcare.
Regulatory Affairs Analyst for Grupo GSH, overseeing compliance with health regulations and documentation processes. Supporting various internal teams and liaising with regulatory bodies.
Pensions Risk and Compliance Manager responsible for ensuring compliance in pension operations at TfL. Handling regulatory and legislative compliance while managing operational risks and quality issues.