Job Title: Manager, TMF Operations
Company: ICON plc – Strategic Solutions
Location: India (Bangalore – Office Based)
Job ID: 2025-118574
About the Role:
ICON plc, a global healthcare intelligence and clinical research organization, is hiring a Manager, TMF Operations to lead and oversee Trial Master File (TMF) operations. The role involves managing document management activities in alignment with study requirements, SOPs, and global regulations while fostering a culture of continuous improvement and operational excellence.
Key Responsibilities:
Uphold and exemplify ICON’s core values focused on People, Clients, and Performance.
Foster a culture of process improvement, continuously enhancing TMF operations to better serve clients and business objectives.
Lead and manage TMF departmental activities to ensure compliance with client specifications, SOPs/WPs, and applicable regulatory guidelines.
Maintain regular communication with department management regarding training needs, project status, quality concerns, and timeline adherence.
Ensure thorough and compliant tracking of document-related activities such as receipt, review, scanning, indexing, quality control, filing, and archiving.
Guarantee the proper maintenance of document files and storage systems according to ICON and regulatory standards.
Qualifications & Experience:
Education:
Bachelor’s degree in Life Sciences, Clinical Research, or a related discipline.
Professional Experience:
Significant experience in TMF management or clinical operations within the pharmaceutical or clinical research industry.
In-depth knowledge of GCP, ICH guidelines, and international regulatory requirements for TMF and clinical documentation.
Demonstrated leadership capability with experience in managing and developing high-performing teams in a regulated, dynamic environment.
What ICON Offers:
ICON’s commitment to its people is reflected in a supportive, inclusive culture and a robust benefits package, including:
Annual leave entitlements tailored to local standards.
Health insurance options to match individual and family needs.
Retirement planning programs designed to support your long-term goals.
TELUS Health Global Employee Assistance Programme, providing access to 80,000+ specialists worldwide.
Life assurance and customizable benefits such as childcare vouchers, gym discounts, travel subsidies, health check-ups, and more.
Explore all benefits at ICON Careers
Inclusion & Equal Opportunity:
ICON is committed to creating a diverse and inclusive workplace free from discrimination and harassment. All qualified applicants will be considered without regard to race, gender, disability, or other protected statuses. Accommodations are available for individuals with disabilities via Reasonable Accommodations.
Note:
If you’re unsure about meeting all listed qualifications, we still encourage you to apply — you may be exactly who ICON is looking for in this or future roles.
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