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Tmf Specialist

1-15 years
Preffered by Company
10 Sept. 3, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

Position: TMF Specialist I

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

Company Overview:

ICON plc is a leading global healthcare intelligence and clinical research organization dedicated to advancing clinical development and improving patient outcomes. Our inclusive culture fosters innovation and excellence, making us a trusted partner in drug development. Join us and be part of a dynamic team that drives industry-leading solutions in clinical research.

Role Overview:

As a TMF Specialist I, you will be a crucial member of our team, responsible for managing trial master file (TMF) activities in support of client services and internal ICON business needs. This role offers the opportunity to work in a fast-paced environment with a focus on document management and regulatory compliance.

Key Responsibilities:

  • Document Management: Process study documents according to client and study requirements, ICON SOPs/WPs, and relevant regulations.
  • Liaison: Collaborate with study teams and other TMF staff to fulfill job responsibilities and ensure smooth workflow.
  • Project Completion: Handle departmental projects within specified timelines, following ICON SOPs/WPs and regulatory requirements.
  • File Maintenance: Maintain study files in accordance with study, client, or ICON requirements.
  • Document Handling: Manage document receipt, review, scanning, indexing, quality control, copying, filing, forwarding, and archiving.
  • Reporting: Provide necessary information for client and departmental status reports.
  • Training and Audits: Participate in training, client audits, ICON audits, and document archiving as required.
  • Client Interaction: Address project issues with clients as directed and handle special projects or duties assigned by the manager.

Requirements:

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

Why Join ICON?

At ICON, we prioritize ongoing development and career progression. We offer competitive salaries, comprehensive benefits packages including health coverage, paid time off, income protection insurance, and staff recognition programs. Our environment encourages personal growth and offers a supportive atmosphere with opportunities to work alongside some of the brightest minds in the industry.

Benefits Include:

  • Competitive salary packages and annual bonuses
  • Health insurance options for you and your family
  • Retirement planning and life assurance
  • Global Employee Assistance Programme
  • Flexible, country-specific benefits such as childcare vouchers, discounted gym memberships, and more

Equal Opportunity Employment:

ICON is committed to providing an inclusive workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Accommodation:

If you need a reasonable accommodation due to a medical condition or disability during the application process or to perform essential job functions, please let us know.

Interested in Applying?

If you’re passionate about advancing clinical development and ready to contribute to a leading organization, apply now. Current ICON employees should apply through our internal career site.

Join ICON and help shape the future of clinical research!