TMF Program Lead

American Health Packaging; United Kingdom; Remote; GBP 45,000 - 70,000; Full time

Job summary

A global pharmaceutical solutions company is seeking a TMF Program Lead for a remote 6-month contract in the UK. This role involves managing Trial Master Files and ensuring inspection readiness while maintaining key customer relationships. The ideal candidate should possess in-depth knowledge of TMF management and clinical trial documentation practices.

Qualifications

• 5 years in a TMF Study Owner or equivalent role.
• In-depth knowledge of clinical trial lifecycle and TMF lifecycle.
• Ability to oversee audits and inspections.

Responsibilities

• Oversee TMF Management and Improvement Strategies.
• Conduct trend analysis of TMF metrics.
• Manage customer relationships and support team development.

Skills

Good Documentation Practices

TMF Reference Model

eTMF systems

Inspection Readiness

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!

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.

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 months.

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.

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.
• 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.
• Team Management
• Manage workload resourcing and oversight of KPIs to ensure continued quality of customer deliverables.
• Support team recruitment and retention.
• The employee agrees to take over additional reasonable tasks that align with their abilities, if required

Work Experience:

• 5 years in a TMF Study Owner or equivalent role

#LI-AT1

.

Skills and Knowledge:

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

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

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

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.

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 months.

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.

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

Work Experience:

• 5 years in a TMF Study Owner or equivalent role

#LI-AT1

.

Skills and Knowledge:

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

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:

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Cencora is a leading global pharmaceutical solutions company that is committed to improving the lives of people and animals everywhere. We connect manufacturers, providers, and patients to ensure that anyone can get the therapies they need, where and when they need them.

We’re a purpose-driven organization, where all of our team members around the world are united in our responsibility to create healthier futures. We work together every day to help our partners bring their innovations to patients worldwide, creating unparalleled access and impact at the center of health.

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