TMF Programme Lead (US region only)

*Phlexglobal is a Pharmalex Company

Phlexglobal (a Pharmalex Company) is the leading technology and services organisation for clinical and regulatory matters with a focus on helping clients to master their digital agenda via proven AI solutions. Phlexglobal combines software and leading expert services to offer a unique solutions portfolio with easy to achieve automation via data generation that lifts organisations to a new level of effectiveness.
TMF Programme Lead
The Professional Services team at Phlexglobal (a PharmaLex company) are a diverse set of individuals with unique expertise and experience, offering Study Resources, Study Services and Consulting Services to customers. The services are designed to work independently as well as collaboratively, fitting the customer’s needs and budget.
Purpose
The TMF Programme 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-focussed partnership with both the customer and study teams.
This is a fully remote role with working hours expected to match the requirements of the customer’s business day. Travel is not an expectation of the role, however occasional travel may be required depending on customer requirements, for example in the case of an inspection or to complete paper TMF activities.
Key Activities
TMF Management

• Oversee TMF management, identifying and sharing strategies to improve management at a portfolio and/or organization level.

TMF Health & Metrics

• 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 (e.g., Heatmaps) outputs and support customer delivery.
• Review portfolio level metrics and provide trend analysis.
• Recommend strategies to improve metrics at a portfolio level.

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, comments and/or support development of Policies and Procedures relating to TMF Operations.

Training & Mentoring

• Support SO 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.

Minimum Required Skills & Experience
Technical Expertise

• 5 years in a TMF Study Owner or equivalent role.
• 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

Soft Skill Expertise

• 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

Phlexglobal, a Pharmalex Company, is an equal opportunity employer and welcomes everyone to join our growing team. At Phlexglobal we make sure that we comply equality, diversity and inclusion in all our offices and prohibit against any discrimination on basis of race, religion, colour, sex, age, martial status or disability status etc.