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ICON Strategic Solutions · 2 hours ago

Manager, Trial Master File Oversight position.

United States

Full-time

Remote

Mid, Senior Level

$95K/yr - $95K/yr

5+ years exp

ICON Strategic Solutions is hiring a Manager for the Trial Master File Oversight position. The role involves strategic oversight, operational management, and continuous improvement of the Trial Master File across clinical studies, ensuring completeness, accuracy, and inspection readiness.

Pharmaceuticals

H1B Sponsor Likely

Hiring Manager

Scott Greenwood

Responsibilities

Provide end-to-end oversight of the Trial Master File (internally and externally managed eTMF). Serve as the eTMF business owner

Ensure TMF completeness, accuracy, and timeliness in accordance with ICH-GCP, regulatory requirements, and internal SOPs

Lead TMF quality review activities, including periodic QC, reconciliation, and ongoing completeness checks

Ensure TMF inspection readiness and support internal, sponsor, and regulatory inspections and audits

Qualification

TMF oversightETMF systemsICH-GCP knowledgeClinical research experienceQuality controlBachelor’s degreeInspection supportReconciliation

Required

Bachelor's degree in Life Sciences, Health Sciences, or a related field required

5+ years of clinical research experience with direct TMF or eTMF oversight

Hands-on experience with TMF quality control, reconciliation, and inspection support

In-depth knowledge of ICH-GCP, TMF Reference Model, and global regulatory requirements

Strong experience with industry-standard eTMF systems (e.g., Veeva Vault TMF or similar)

Company

ICON Strategic Solutions

ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.

Dublin , GB

10001+ employees

https://www.iconplc.com/services/strategic-solutions/

H1B Sponsorship

ICON Strategic Solutions has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (1)

2022 (1)

2021 (2)

2020 (3)

Funding

Current Stage

Late Stage

Leadership Team

Jennifer Alamo Linnell

VP, HR Business Partnering

Aimée Guzmán

External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines

Company data provided by crunchbase