Job Title:
TMF Lead
Location:
United States (Remote)
Job ID:
2025-117818
Department:
Regulatory Affairs (ICON Strategic Solutions)
Job Type:
Full-Time, Remote
Application Contact:
Name: Brendan Hoey
Message Option: Send a message via job platform
Other Roles: View other roles by Brendan
Job Description:
About ICON:
ICON plc is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence, providing innovative solutions for clinical trials.
Key Responsibilities:
Maintain effective communication with eTMF Manager, clinical trial teams (CTT), CRO staff, and eTMF vendors throughout trial start-up, maintenance, and close-out.
Facilitate periodic completeness reviews of trial TMF content, ensuring quality and completeness.
Provide orientation and training on the TMF quality review process to the CTT.
Perform risk assessments and determine scope for review, ensuring expected document lists (EDLs) are complete.
Ensure documents are present, correctly filed, meet Good Documentation Practice (GDP) and Good Clinical Practice (GCP) standards, and comply with regulatory requirements.
Use cross-functional analysis to detect missing documents or gaps in the TMF, providing solutions for remediation.
Track and report progress of quality issue resolution and escalate non-compliance as needed.
Perform routine quality checks for documents uploaded into the eTMF.
Attend departmental and trial-specific meetings as required.
Support the Clinical Trial Systems Operations team with other TMF document-related tasks.
Qualifications & Experience:
Education: BA/BS required or equivalent subject experience.
Experience: At least 2 years of experience in clinical research within the pharmaceutical or biotech industry.
Skills:
Experience in eTMF completeness and quality oversight in a TMF or Clinical Operations setting.
Proficiency in clinical research documents, their contents, and purpose.
Knowledge of ICH/GCP guidelines and applicable regulatory rules.
Strong communication, organizational, and prioritization skills.
Proficiency with eTMF applications and completeness reviews.
ICON Employee Benefits Include:
Generous annual leave
Health insurance options for you and your family
Competitive retirement savings plans
Global Employee Assistance Programme (TELUS Health)
Life assurance
Country-specific optional benefits, such as:
Childcare vouchers
Bike-to-work schemes
Discounted gym memberships
Subsidized travel passes
Health assessments
More information: ICON Benefits Overview
Diversity & Inclusion Commitment:
ICON is dedicated to providing an inclusive and accessible environment for all candidates, ensuring equal employment opportunities without discrimination.
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