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Tmf Specialist (All Levels)

1-15 years
Not Disclosed
10 June 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Summary:

ICON plc, a global leader in healthcare intelligence and clinical research, is hiring TMF Specialists (All Levels) for its Bangalore and Chennai offices. This role involves handling document management activities that support client services and internal ICON business needs within the regulatory document management function. If you have 1–15 years of TMF experience and a life sciences background, this is a fantastic opportunity to join a world-class organization known for innovation and excellence.


Key Responsibilities:

  • Process study documents as per study-specific processes, ICON SOPs/WPs, and applicable regulations.

  • Coordinate with study teams and TMF staff to manage job responsibilities effectively.

  • Maintain and organize study files as per client and ICON requirements.

  • Handle document receipt, quality control, scanning, indexing, filing, and archiving activities.

  • Support departmental projects while adhering to project timelines.

  • Provide updates and information for client or departmental status reports.

  • Assist in client and/or ICON audits and document archiving activities.

  • Participate in regular training programs as per client and ICON standards.

  • Communicate effectively with clients, study teams, and management as needed.

  • Handle additional projects or duties assigned by the Manager.


Required Skills & Qualifications:

  • Experience: 1–15 years in TMF (Trial Master File) management.

  • Strong knowledge of clinical studies documentation.

  • Bachelor’s Degree in Life Sciences preferred.

  • Excellent verbal and written communication skills.

  • Ability to collaborate with cross-functional teams, clients, and management.


Perks & Benefits:

  • Competitive salary packages and annual performance-based bonuses.

  • Comprehensive health insurance coverage for you and your family.

  • Retirement plans, life assurance, and income protection programs.

  • Paid time off and flexible working benefits.

  • Global Employee Assistance Programme for well-being support.

  • Access to subsidized gym memberships, childcare vouchers, travel passes, and more.


Company Description:

ICON plc is a global provider of outsourced development services to the pharmaceutical, biotechnology, and medical device industries. Known for delivering excellence in clinical research, ICON fosters an inclusive and innovative environment to help shape the future of healthcare.


Work Mode:

Hybrid (Office-based) – Locations: Bangalore, Chennai


Call-to-Action:

If you are passionate about clinical research and TMF management, apply now to be part of a dynamic team at ICON that is shaping the future of drug development.


SEO Notes:

This post targets high-ranking keywords such as TMF Specialist jobs India, Trial Master File jobs Bangalore Chennai, Clinical Research jobs, and ICON careers India to enhance search visibility and indexing.