[Hiring] Freelance Clinical Database Programming Process Lead @TFS HealthScience

Role Description

Join Our Team as a Freelance Clinical Database Programming Process Lead (1.0 FTE) - home based in UK, Germany, Poland, Portugal, Spain or office based in Sweden.

As part of our CDS Group Management (Operations) team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Freelance Clinical Database Programming Process Lead is responsible for developing and sustaining a consistent, scalable and high-quality clinical database programming capability across TFS.

Key Responsibilities

• Outcome-based role with expected deliverables agreed at start-up.

Key Deliverables

• Capability Assessment and Improvement Roadmap
• Database Programming (DBP) current-state capability and risk assessment.
• DBP Capability Plan and prioritised improvement roadmap.
• DBP governance model, including roles, responsibilities, escalation routes and cross-BU forum structure.
• Track delivery of agreed roadmap, and manage risk to progress.

Quality, Compliance and Inspection Readiness

• Review of relevant SOPs, Work Instructions, templates and controlled documents, with efficiency, compliance and alignment change recommendations.
• Review quality trends, systemic risks and improvements.
• Support consistent application of validation, testing, change control, documentation and database build activities.
• Support or prepare for audits and inspections where DBP process expertise required.

Technical Leadership and Escalation Support

• Act as senior DBP technical escalation point for complex, high-risk or strategically important DBP issues.
• DBP knowledge repository and reusable standards/library structure.
• Future EDC platform readiness assessment and recommendations.
• Provide targeted hands-on DBP support where needed to protect delivery.

Training, Competency and Workforce Development

• DBP competency framework and training plan.
• DBP onboarding pathway for new hires and contractors. Support recruitment criteria, interview assessment materials and technical evaluation of DBP candidates.
• Deputy, backup and succession plan for DBP capability.
• Support mentoring and coaching of DBP personnel and potential deputies.

Commercial, Proposal and Business Support

• Standard DBP costing/proposal assumptions and sales support guidance.
• Provide SME input for bid defence preparation or client discussions involving DBP capability, EDC platform readiness or database programming considerations.
• Agreed quality and effectiveness measures for handover and sustainability.

Qualifications

• 5 - 10 years database programming experience in a CRO, pharmaceutical, biotechnology or clinical research environment.
• Strong technical knowledge of clinical database build, validation, edit checks, data transfer programming, database lock and EDC study set-up processes.
• Experience with one or more major EDC/CDMS platforms, with ability to work across multiple systems.
• Strong understanding of GxP expectations relevant to clinical systems, database programming, validation, testing, documentation and inspection readiness.
• Experience developing or improving SOPs, Work Instructions, templates, standards, training materials or process documentation.
• Experience providing technical training, mentoring or coaching to database programming staff.
• Ability to work across multiple Business Units and stakeholder groups without direct line authority.
• Strong analytical, problem-solving and practical risk-based decision-making skills.
• Clear written and verbal communication skills, with ability to translate technical DBP issues into practical business recommendations.
• Ability to work independently and deliver structured outputs within a fixed-term assignment.

Benefits

• Competitive compensation package.
• Comprehensive benefits.
• Opportunity for personal and professional growth in a rewarding environment.