Global TMF Ops Associate II – Remote

Worldwide; Town of Poland (NY); Hybrid; USD 60,000 - 90,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to support Europe/Latam in a remote/hybrid setup. The role focuses on TMF approval, QC review, and handling document workflows across sponsor portfolios. A degree in life sciences and TMF exposure are preferred.

The position involves working with SOPs, regulatory requirements, and electronic TMF systems in a dynamic CRO environment, with opportunities to collaborate with global teams.

Qualifications

• University degree preferred; life sciences background encouraged.
• 1–2 years TMF experience in CRO/Pharma environment advantageous.

Responsibilities

• Fulfil the TMF Approver and/or TMF QC Reviewer roles per SOPs.
• Process and resolve TMF documents for complex studies and sponsor portfolios.
• Prepare periodic TMF QC checklists for Project Team review.
• Perform periodic TMF QC to ensure regulatory and ICH GCP compliance.
• Work with electronic document management and TMF systems to review and classify documents.

Skills

Data collection

Indexing

Editing

Communication

Interpersonal skills

Planning

Organization

MS Word

Excel

eTMF

Education

University Degree (Life Science preferred)

Tools

MS Word

Excel

eTMF systems

Job description

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to support Europe/Latam in a remote/hybrid setup. The role focuses on TMF approval, QC review, and handling document workflows across sponsor portfolios. A degree in life sciences and TMF exposure are preferred.

The position involves working with SOPs, regulatory requirements, and electronic TMF systems in a dynamic CRO environment, with opportunities to collaborate with global teams.