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Tmf Specialist (All Levels)

1-15 years
Not Disclosed
10 Oct. 25, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Company Overview

ICON plc is a world-leading healthcare intelligence and clinical research organization dedicated to fostering an inclusive environment that drives innovation and excellence. Join us on our mission to shape the future of clinical development.

At ICON, our people set us apart. Our diverse teams enhance our ability to partner with customers and fulfill our mission to advance and improve patients’ lives.

Our 'Own It' culture is built on four key values: Accountability & Delivery, Collaboration, Partnership, and Integrity. We aim to be the Clinical Research Organization that delivers excellence at every touchpoint, making us the partner of choice in drug development.

Position Summary

Location: Chennai, India (Hybrid: Office-based)

As a TMF Specialist I, you will support Document Management activities to meet client service contracts and internal ICON business needs.

Key Responsibilities

  • Process study documents per client and study requirements, adhering to ICON SOPs/WPs and applicable regulations.
  • Liaise with study teams and TMF staff to fulfill job responsibilities effectively.
  • Complete departmental projects in accordance with specified timelines and regulations.
  • Maintain study files according to study and/or client requirements.
  • Manage document receipt and processing, including scanning, indexing, quality control, copying, filing, and archiving.
  • Provide necessary information for client and departmental status reports as requested.
  • Inform the Manager of training issues, project activities, quality concerns, and timelines.
  • Supply copies of study documents to ICON or client personnel as requested.
  • Participate in client and ICON audits and document archiving activities as needed.
  • Engage in training related to your responsibilities as required by ICON and/or the client.
  • Handle special projects or duties as assigned by the Manager.

Requirements

  • Experience: 1-15 years of experience in TMF (Trial Master File) with a strong understanding of clinical study documents.
  • Skills: Strong oral and written communication skills and the ability to liaise effectively with project teams, clients, and management.
  • Education: Bachelor’s degree in Life Sciences preferred.

Why Join Us?

At ICON, ongoing development is vital. You will have opportunities to progress your career and enhance your skill set. We offer a competitive salary and benefits package, including health coverage, paid time off, income protection insurance, and staff recognition schemes.

Benefits of Working at ICON

  • Competitive salary packages benchmarked against industry standards.
  • Annual bonuses reflecting performance goals.
  • Comprehensive health benefits for employees and families.
  • Competitive retirement plans and life assurance.
  • A supportive environment focused on your well-being and work-life balance.

Equal Opportunity Employer

ICON is committed to providing a workplace free from discrimination and harassment. We offer equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you need reasonable accommodation during the application process, please let us know.

Interested in the Role?

We encourage you to apply even if you don’t meet every requirement. You might be exactly what we’re looking for at ICON.

If you are a current ICON employee, please click here to apply.