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Tmf Lead

2-5 years
Preffered by Company
10 Sept. 3, 2024
Job Description
Job Type: Full Time Remote 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 Compliance Associate

Company Overview:

Join ICON plc, the world’s largest and most comprehensive clinical research organization, where we leverage healthcare intelligence to drive innovation and excellence in clinical development.

Role Overview:

As a TMF Compliance Associate, you will play a pivotal role in overseeing and managing Trial Master File (TMF) systems, processes, and learning strategies. You will collaborate with various departments and stakeholders to ensure TMF strategies align with business needs, client requirements, and regulatory expectations.

Key Responsibilities:

  • Oversight and Compliance: Provide oversight of TMF systems and processes, ensuring compliance with both internal and external requirements.
  • Collaboration: Work closely with the TMF Process Owner and IT, liaising with subject matter experts and leaders across departments to align TMF strategies with business needs and regulatory expectations.
  • Liaison Role: Act as the primary liaison between operations and Corporate Services, including IT, Process and Learning Management, etc.
  • Project Management: Handle assignments related to new process initiatives, client requirements, system configuration and validation, vendor management, and CAPA representation.
  • Maintenance and Improvement: Oversee and maintain existing TMF practices while driving process improvements and training initiatives.

What You Need:

  • Education and Experience: Undergraduate degree (or its international equivalent from an accredited institution). Alternatively, 2-5 years of industry experience in a TMF-related role can substitute for educational qualifications.
  • Skills and Knowledge:
    • Demonstrated expertise in managing both paper and electronic Trial Master Files.
    • Fluency in English and the host country language.
    • Prior experience in leading TMF functions or projects.
    • Familiarity with ICH/GCP, local regulatory authority, and clinical development regulations.
    • Understanding of System Development Lifecycles.
  • Certifications: Certification in Project Management, Six Sigma, or LEAN is preferred.

Why ICON?

At ICON, we are committed to offering a comprehensive and competitive total reward package. This includes:

  • Base Pay: Competitive base salary with variable pay and recognition programs.
  • Benefits: Best-in-class employee benefits, including health coverage, retirement plans, and well-being initiatives.
  • Professional Development: Opportunities for continuous learning and career growth within a supportive and dynamic environment.

Equal Opportunity Employment:

ICON is an equal opportunity and inclusive employer, dedicated to creating 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.

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.

Application:

If you’re interested in this role but unsure if you meet all the requirements, we encourage you to apply. You might be exactly what we’re looking for at ICON, whether for this role or others.

Ready to Apply?

Join ICON and contribute to shaping the future of clinical research. Apply today!