Remote TMF Operations Associate II

Worldwide Clinical Trials; Georgia; Vor Ort; USD 50.000 - 75.000; Vollzeit

Zusammenfassung

Worldwide Clinical Trials seeks a TMF Operations professional to manage Trial Master File processes and ensure regulatory compliance across studies. You will collaborate with study teams to maintain accurate TMF records.

Responsibilities include reviewing documents, preparing quality-control checklists, and using electronic TMF systems to classify and file essential records. Prior TMF exposure in CRO/Pharma is preferred.

Qualifikationen

• University Degree preferred; Life Science background desirable.
• Up to 1–2 years of TMF experience in CRO/Pharma.
• Familiarity with regulatory requirements and ICH GCP.
• Strong written and verbal communication and organizational skills.

Aufgaben

• Fulfil TMF Approver and/or TMF QC Reviewer roles as defined by SOPs.
• Process, review, and resolve rejected TMF documents for complex studies.
• Prepare periodic TMF quality control checklists for project teams.
• Perform periodic TMF quality control to ensure regulatory compliance.
• Work with electronic TMF systems to review and classify documents.

Kenntnisse

Data collection

Indexing

Editing

Written communication

Verbal communication

Interpersonal skills

Time management

MS Word

MS Excel

eTMF System

Clinical research knowledge

Ausbildung

University Degree preferred (Life Science desirable)

Tools

MS Word

MS Excel

eTMF System

Jobbeschreibung

Worldwide Clinical Trials seeks a TMF Operations professional to manage Trial Master File processes and ensure regulatory compliance across studies. You will collaborate with study teams to maintain accurate TMF records.

Responsibilities include reviewing documents, preparing quality-control checklists, and using electronic TMF systems to classify and file essential records. Prior TMF exposure in CRO/Pharma is preferred.