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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

Document Management

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

• Process, upload, and index TMF documents

• Track and maintain TMF documentation

Document Quality

• Perform in-line document QC

TMF Management

• 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

TMF Metrics

• Run metrics reports, communicating output

• Identify and share high-level trends in metrics reports

TMF Health

• Perform TMF quality review (QR)

• Communicate QR findings and identify high-level trends

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

Inspection Readiness

• Support remediation projects, including query management and remediation tasks

• Support retrospective TMF reconciliation projects, performing assigned tasks

Customer Relationships

• Understand and utilise appropriate escalation pathways

• Communicate with the study team on TMF-related matters

• Choose an item

The employee agrees to take over additional reasonable tasks that align 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 oversight

• 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 Quality Review Process

-   Internal communication/escalation pathways

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 pathways

Independent in:

-   Verbal and written communication

-   Interpersonal interactions

-   Organization-   External collaboration

-   Negotiation/conflict resolution

-   Working under pressure

-   Information analysis

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What Cencora offers

​Benefit offerings outside the US may vary by country and will be aligned 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

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora 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 [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned