Instagram
youtube
Facebook

Tmf Specialist Ii

2+ years
Not Disclosed
10 Aug. 22, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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 the Role

As a TMF Specialist II at ICON, the world’s largest and most comprehensive clinical research organization, you will play a critical role in maintaining the integrity and quality of trial master files (TMF). This role involves collaborating closely with clinical trial teams and CRO staff throughout all phases of a clinical trial, from start-up through to close-out and archival.

Key Responsibilities:

  • Effective Communication: Maintain clear and ongoing communication with clinical trial teams and CRO staff to ensure smooth trial operations.
  • eTMF Health Management: Oversee the Quality Issue (QI) lists for assigned trials, ensuring timely remediation of documents that fail quality control or review. Reassign and close QIs as necessary.
  • Document Oversight: Manage Expected Document Lists (EDL) and document counts for the duration of trials, working closely with Clinical Trial Teams (CTT) and CRO teams. Escalate non-compliance issues to the eTMF Manager as needed.
  • Metrics and Reporting: Provide scheduled and ad-hoc analyses on TMF health to eTMF Managers and CTT/CRO teams.
  • TMF Documentation: Support the filing of TMF documents into the Moderna eTMF system. Maintain and follow naming and filing guidelines for TMF documents. Conduct quality checks and review document content.
  • Inspection and Audit Support: Prepare for and assist with inspection and audit activities. Address inquiries related to TMF management and contents.
  • Continuous Learning: Stay current with the TMF Reference Model, industry best practices, and regulatory requirements.
  • Administrative Tasks: Perform general administrative duties related to assigned trials and complete other TMF-related tasks as assigned by the eTMF Manager or department head.

Qualifications:

  • Bachelor’s degree in a science or healthcare-related field.
  • Minimum of 2 years of experience in a clinical research setting, with at least 1 year of experience in eTMF document management preferred.
  • Strong organizational and prioritization skills, with a keen attention to detail.

Why ICON?

At ICON, we are committed to offering a comprehensive total rewards package that includes competitive base pay, variable pay, and recognition programs. We provide exceptional employee benefits, supportive policies, and wellbeing initiatives designed to support you and your family throughout your career. Our success relies on the expertise and quality of our people, which is why we invest in continuous learning and professional development. ICON is an equal opportunity employer committed to creating a diverse and inclusive workplace free from discrimination and harassment. If you require accommodation due to a medical condition or disability, please let us know.

Interested in the Role?

If you’re interested but unsure if you meet all the requirements, we encourage you to apply. You might be the perfect fit for this role or other opportunities at ICON.