TMF Program Lead

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

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.

Experience and Educational Requirements

- 5 years in a TMF Study Owner or equivalent role

Minimum Skills, Knowledge and Ability Requirements

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

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

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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