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Tmf Specialist (All Levels)

1-15 years
Not Disclosed
10 Oct. 29, 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

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

At ICON, our people set us apart. Our diverse teams enable us to become better partners to our customers, helping us fulfill our mission to advance and improve patients’ lives. Our "Own It" culture is rooted in four key values: Accountability & Delivery, Collaboration, Partnership, and Integrity. We aim to be the Clinical Research Organization that delivers excellence to clients and patients at every touchpoint.

The Role:
As a TMF Specialist I, you will support Document Management activities related to client services contracts and internal ICON business needs.

Responsibilities:

  • Process study documents in line with client and study requirements, adhering to ICON SOPs/WPs and relevant regulations.
  • Liaise with study teams and other TMF staff to fulfill responsibilities effectively.
  • Complete departmental projects as assigned, ensuring adherence to timelines and regulations.
  • Maintain study files per study/client requirements and ICON SOPs/WPs.
  • Handle document receipt and processing tasks, including reviewing, scanning, indexing, and archiving.
  • Provide necessary information for client and departmental status reports as requested.
  • Inform the Manager of training issues, project activities, quality issues, and timelines.
  • Participate in audits and document archiving activities as needed.
  • Assist in training sessions related to your responsibilities.
  • Address project issues with clients as directed by the Manager.
  • Undertake special projects or additional duties as requested.

Qualifications:

  • 1-15 years of TMF (Trial Master File) experience with strong knowledge of clinical study documents.
  • Ability to effectively liaise with study project teams, staff, clients, and management.
  • Excellent oral and written communication skills.
  • Bachelor’s Degree in Life Sciences preferred.

Why Join Us:
Ongoing development is essential at ICON, and as a team member, 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:

Our success depends on the quality of our people. We prioritize a culture that rewards high performance and nurtures talent:

  • Competitive salary packages, regularly benchmarked against industry standards.
  • Annual bonuses based on performance goals.
  • A range of health-related benefits for employees and their families.
  • Competitive retirement plans and life assurance.
  • An environment that encourages purpose and drives lasting change.

Diversity Commitment:
ICON is an equal opportunity and inclusive employer, dedicated to providing a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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

Encouragement to Apply:
Not sure if you meet all the requirements? We encourage you to apply anyway—there’s a good chance you’re exactly what we’re looking for at ICON, whether for this role or others.

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