TMF Program Lead

Phlexglobal

206d

About The Position

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.

Requirements

• 5 years in a TMF Study Owner or equivalent role.
• In-depth knowledge of Good Documentation Practices (GDP).
• In-depth knowledge of TMF Reference Model (or equivalent).
• Excellent knowledge of document recognition.
• Excellent knowledge of clinical trial lifecycle.
• Excellent knowledge of TMF lifecycle.
• Excellent knowledge of other clinical/document management systems.
• Excellent knowledge of TMF stakeholders.
• Excellent knowledge of end to end tasks, including TMF set-up process, Management Plan, Health & Metrics, Quality Review process.
• Excellent knowledge of TMF training.
• Excellent knowledge of Inspection Readiness.
• Excellent knowledge of internal and external communication/escalation pathways.

Responsibilities

• Oversee TMF Management, identifying and sharing strategies to improve management at a portfolio and/or organization level.
• Review portfolio level metrics and provide trend analysis.
• Recommend strategies to improve metrics at a portfolio level.
• 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.
• 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.
• 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.
• Review, comment and/or support development of Policies and Procedures relating to TMF Operations.
• Support study resources development, identifying training and personal development opportunities.
• Develop and oversee implementation of internal and/or external TMF-related trainings.
• Manage workload resourcing and oversight of KPIs to ensure continued quality of customer deliverables.

Benefits

• Medical, dental, and vision care.
• Backup dependent care.
• Adoption assistance.
• Infertility coverage.
• Family building support.
• Behavioral health solutions.
• Paid parental leave.
• Paid caregiver leave.
• Training programs.
• Professional development resources.
• Opportunities to participate in mentorship programs.
• Employee resource groups.
• Volunteer activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services