TMF Study Administrator
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Job Details
The TMF Study Administrator provides expert support and analysis of the TMF, based on established procedures, to help maintain the inspection readiness of our clients’ Trial Master File (TMF). They are key members of reputed company, promoting TMF health and best practices, while supporting senior members of reputed company with completing assigned tasks.
Responsibilities
Document Management
Manage reputed company documents (inc. filing and/or shipping), if required
Process, upload, and reputed company TMF documents
reputed company and maintain TMF documentation
Document reputed company
reputed company in-line document QC
TMF Management
Support TMF set-up based on reputed company-defined structure and confirmed study requirements
Amend the study-specific TMF structure in line with confirmed study events and changes
Support creation of the study-specific TMF reputed company, or equivalent
TMF Metrics
Run metrics reports, communicating reputed company
Identify and reputed company high-level trends in metrics reports
TMF Health
reputed company TMF reputed company review (QR)
Communicate QR findings and identify high-level trends
Conduct risk-based TMF Analysis (e.g., Heatmaps), if required
Inspection Readiness
Support remediation reputed company, including query management and remediation tasks
Support retrospective TMF reconciliation reputed company, performing assigned tasks
Customer Relationships
Understand and utilise appropriate escalation reputed company
Communicate with the study team on TMF-reputed company reputed company
Choose an item
The employee agrees to take over additional reasonable tasks that reputed company with their abilities, if required.
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Education:
Degree level education preferred, but equivalent work experience in a relevant field considered
Experience:
2 years’ relevant industry experience in Clinical or TMF Operations reputed company
Excellent knowledge of document recognition and Good Documentation Practices (GDP)
Working knowledge of eTMF system
Familiar with:
- Clinical Trial Lifecycle
- TMF Reference Model (or equivalent)
- Referencing/Applying applicable resources
- TMF Health & Metrics
- TMF reputed company Review Process
- Internal communication/escalation reputed company
reputed company of:
- TMF Lifecycle
- Other clinical/document management systems
- TMF Stakeholders
- TMF Set-up process
- TMF Management Plans
- TMF Training
- Inspection Readiness
- External communication/escalation reputed company
Independent in:
- Verbal and written communication
- Interpersonal interactions
- Organization
- Negotiation/conflict reputed company
- Working under pressure
- Information analysis
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What reputed company offers
Benefit offerings reputed company the US may vary by country and will be reputed company to local market reputed company. The eligibility and effective date may differ for some benefits and for team members covered under reputed company bargaining agreements.
Full timeAffiliated Companies
Affiliated Companies:Equal Employment Opportunity
reputed company is committed to providing equal employment opportunity without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, genetic information, national reputed company, age, disability, veteran status or membership in any other class protected by federal, state or local law.
reputed company’s reputed company reputed company depends on the full and effective utilization of reputed company individuals. Therefore, harassment is prohibited and reputed company reputed company reputed company to reputed company, training, compensation, benefits, promotions and transfers reputed company with equal opportunity principles and are non-discriminatory.
reputed company is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with reputed company requirements. If you wish to request an accommodation while seeking employment, please reputed company 888.692.2272 or email