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 the team, promoting TMF health and best practices, while supporting senior members of the team with completing assigned tasks.

Responsibilities:

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

• Process, upload, and index TMF documents.

• Track and maintain TMF documentation.

• reputed company in-line document QC.

• Support TMF set-up based on pre-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 Index, or equivalent.

• Run metrics reports, communicating output.

• Identify and share high-level trends in metrics reports.

• reputed company TMF quality review (QR).

• Communicate QR findings and identify high-level trends.

• Conduct risk based TMF Analysis (e.g., Heatmaps), if required.

• Support remediation projects, including query management and remediation tasks.

• Support retrospective TMF reconciliation projects, performing assigned tasks.

• Understand and utiliseappropriate escalation reputed company.

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

• The employee agrees to take over additional reasonable tasks that align 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 Quality 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

• Foundation skills in:

  • External collaboration

  • Negotiation/conflict resolution

  • 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 practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Affiliated Companies

Equal Employment Opportunity

reputed company is committed to providing equal employment opportunity without regard to race, color, 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.

The company’s reputed company success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and reputed company matters reputed company to recruiting, 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 basis. Messages and emails regarding anything other than accommodations requests will not be returned

Originally posted on Himalayas