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Tmf Specialist (All Levels)

1-15 years
Not Disclosed
10 Oct. 17, 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

Position: TMF Specialist I

Location: Hybrid (Chennai)

Join ICON plc, a leading healthcare intelligence and clinical research organization committed to innovation and excellence. We pride ourselves on fostering an inclusive environment that empowers our diverse teams to advance and improve patients' lives.

Our "Own It" culture is built on four core values: Accountability & Delivery, Collaboration, Partnership, and Integrity. We strive to be the Clinical Research Organization of choice for our clients and patients alike, delivering excellence at every touchpoint.

About the Role:

As a TMF Specialist, you will manage Document Management activities to support client services and internal ICON needs. This is an exciting opportunity to work in a fast-paced environment within a global provider of outsourced development services to the pharmaceutical, biotechnology, and medical device industries.

Key Responsibilities:

  • Process study documents according to client requirements, study-specific processes, ICON SOPs, and applicable regulations.
  • Collaborate with study teams and other TMF staff to fulfill job responsibilities.
  • Complete departmental projects as assigned, adhering to timelines and regulations.
  • Maintain study files in accordance with study or client requirements.
  • Perform document receipt and processing tasks, including review, scanning, indexing, quality control, and archiving.
  • Provide necessary information for client and departmental status reports.
  • Report training issues, project activities, and quality concerns to the Manager.
  • Participate in audits and document archiving activities as needed.
  • Engage in training related to responsibilities and liaise with clients on project issues when directed.
  • Handle special projects or duties as assigned by the Manager.

What You Need:

  • 1-15 years of experience with Trial Master Files (TMF) and strong knowledge of clinical study documents.
  • Excellent oral and written communication and interpersonal skills.
  • Bachelor’s degree in Life Sciences preferred.

Why Join Us:

At ICON, ongoing development is essential. As a team member, you’ll have the opportunity to advance 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 programs.

Benefits of Working at ICON:

Our success relies on our people. We prioritize a culture that rewards high performance and nurtures talent. Our competitive salary packages are regularly benchmarked, and annual bonuses reflect both individual and organizational performance.

We also provide comprehensive health-related benefits and competitive retirement plans, including life assurance, to help you save and plan for the future. Beyond this, we offer an environment that encourages you to fulfill your purpose and drive meaningful change.

Diversity and Inclusion:

ICON is an equal opportunity employer committed to a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you need reasonable accommodations during the application process or to perform essential job functions, please let us know.

Interested in the Role?

If you’re excited about this opportunity but unsure if you meet all the requirements, we encourage you to apply. You might be just what we’re looking for at ICON.

Are you a Current ICON Employee? Please click here to apply.