Offer summary

Qualifications:

5 years of experience in a TMF Study Owner or equivalent role, In-depth knowledge of Good Documentation Practices (GDP) and TMF Reference Model, Excellent understanding of clinical trial lifecycle and TMF lifecycle, Proficient in verbal and written communication, coaching, and negotiation..

Key responsibilities:

Oversee TMF management and improve strategies at a portfolio level

Conduct trend analysis of TMF metrics and provide recommendations

Establish inspection readiness practices and oversee audits

Manage team workload and support training and development opportunities.

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

#LI-AT1

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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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