TMF Program Lead

Cencora, Inc.; United Kingdom; Remote; GBP 50,000 - 80,000; Full time

Job summary

Cencora, Inc. is seeking a TMF Program Lead to manage and enhance Trial Master Files (TMFs) for clinical trials. This remote role entails overseeing TMF management, ensuring quality from portfolio to vendor level, and bolstering customer relationships. Ideal candidates should possess at least 5 years' experience in TMF oversight, strong communication skills, and a proactive approach to risk management.

Qualifications

• 5 years in a TMF Study Owner or equivalent role required.
• In-depth knowledge of Good Documentation Practices and TMF Reference Model.
• Excellent verbal and written communication skills.

Responsibilities

• Oversee TMF Management, ensuring quality and compliance.
• Conduct trend analysis of TMF metrics.
• Establish inspection readiness practices.

Skills

Good Documentation Practices

TMF Reference Model

Verbal and written communication

Coaching & mentoring

Negotiation/conflict resolution

Organization

Information analysis

Education

5 years in a TMF Study Owner or equivalent role

Tools

eTMF systems

Clinical trial lifecycle

Job description

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

We have an exciting opportunity for a TMF Program Lead to join Pharmalex. This is a remote role based in the United Kingdom and it will initially be for 6 motnhs.

Purpose & Contribution Summary

The TMF Program Lead is the key customer contact, acting as a subject matter expert (SME), while also responsible for day-to-day oversight of assigned Study Resources. They are responsible for helping ensure complete and accurate study Trial Master Files (TMFs) through application of a high quality and consistent approach across clinical trials and programs. A champion for inspection readiness, they maintain oversight at a portfolio level, conducting trend analysis of TMF metrics to identify and help facilitate resolution of key risk areas. They are expected to establish a proactive and quality-focused partnership with both the customer and study teams.

Primary Duties and Responsibilities

TMF Management

• Oversee TMF Management, identifying and sharing strategies to improve management at a portfolio and/or organization level.
• TMF Metrics
• Review portfolio level metrics and provide trend analysis.
• Recommend strategies to improve metrics at a portfolio level.
• TMF Health
• Oversee ongoing TMF Health at Portfolio and Vendor level.
• Collate and provide customer feedback on identified trends.
• Provide proactive guidance based on risk based TMF Analysis (e.g., Heatmaps) and QC data.
• Facilitate trend-analysis of TMF Analysis (Heatmap) outputs and support customer delivery.
• Inspection Readiness
• Establish IR oversight practices and guide continuous improvement.
• Report trends and offer remediation strategies for customer CRO governance.
• Implement tools and tracking to ensure overall scope of IR delivery.
• Oversee audits and inspections.
• Support implementation of CAPAs at portfolio level.
• Coordinate with QA to prepare study teams for inspections.
• Customer Relationships
• Focus on relationship w/ Study Management and Leadership at the Organization level.
• Feed back to customer on portfolio, vendor/CRO or therapeutic-line trends
• Oversee a team to ensure escalation pathways are being used effectively.
• Policies & Procedures
• Review, comment and/or support development of Policies and Procedures relating to TMF Operations.
• Training & Mentoring
• Support study resources development, identifying training and personal development opportunities.
• Develop and oversee implementation of internal and/or external TMF-related trainings.
• Team Management
• Manage workload resourcing and oversight of KPIs to ensure continued quality of customer deliverables.
• Assume line management responsibilities.
• Support team recruitment and retention.
• The employee agrees to take over additional reasonable tasks that align with their abilities, if required

Experience and Educational Requirements

• 5 years in a TMF Study Owner or equivalent role

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Minimum Skills, Knowledge and Ability Requirements

In-depth knowledge of:

• Good Documentation Practices (GDP)
• TMF Reference Model (or equivalent)
• Referencing/Applying applicable resources
• eTMF systems
• Excellent knowledge of:
• Document recognition
• Clinical trial lifecycle
• TMF lifecycle
• Other clinical/document management systems
• TMF stakeholders
• End to end tasks, including: TMF set-up process, Management Plan, Health & Metrics, Quality Review process
• TMF training
• Inspection Readiness
• Internal and external communication/escalation pathways

Proficient in:

• Verbal and written communication
• Internal and external collaboration
• Coaching & mentoring
• Negotiation/conflict resolution
• Interpersonal interactions
• Working under pressure
• Organization
• Prioritization
• Information analysis
• Presenting information

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.

Full time

Affiliated Companies

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