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:

• Manage reputed company documents (inc. filing and/or shipping), if required.

• Process, upload, and reputed company TMF documents.

• reputed company and maintain TMF documentation.

• reputed company in-line document QC.

• 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.

• Run metrics reports, communicating reputed company.

• Identify and reputed company high-level trends in metrics reports.

• 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.

• Support remediation reputed company, including query management and remediation tasks.

• Support retrospective TMF reconciliation reputed company, performing assigned tasks.

• Understand and utiliseappropriate escalation reputed company.

• Communicate with the study team on TMF-reputed company reputed company.

• The employee agrees to take over additional reasonable tasks that reputed company with their abilities, if required

.

Requirements:

• 2 years relevant industry experience in Clinical or TMF Operations reputed company.

Minimum Requirements:

• Excellent knowledge of document recognition and Good Documentation Practices (GDP)

• Working knowledge of eTMF systems

• 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

• Aware 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

  • Internal collaboration and prioritization

  • Developing in coaching & mentoring

• reputed company skills in:

  • External collaboration

  • Negotiation/conflict reputed company

  • Working under pressure

  • Information analysis

  • Presenting information

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 time

Affiliated Companies

Affiliated Companies: reputed company UK Services Limited

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 legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@reputed company.com. We will reputed company accommodation determinations on a request-by-request reputed company. Messages and emails regarding anything other than accommodations requests will not be returned

Originally posted on Himalayas

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