• Develop, maintain and deliver the Database Programming capability plan and prioritised improvement roadmap.
• Own and continuously improve the DBP governance and operating model, including roles, responsibilities, decision rights, escalation routes and cross-BU forums.
• Maintain enterprise standards, playbooks, templates, tools, reusable libraries and the DBP knowledge repository.

Quality, Compliance and Inspection Readiness

• Act as process owner or designated SME for relevant global SOPs, Work Instructions, templates and controlled documents, coordinating changes through the applicable QMS process.
• Monitor quality trends, recurring issues, CAPAs and systemic risks, and lead practical, risk-based improvement actions.
• Promote consistent application of validation, testing, change control, documentation, database build and database lock requirements.
• Provide DBP expertise for audits, inspections, client assessments and remediation activities, including preparation and follow-up where required.

Technical Leadership and Escalation Support

• Act as senior DBP technical escalation point for complex, high-risk or strategically important DBP issues
• Provide targeted hands-on support where required to protect delivery, resolve priority issues or address short-term capability gaps.
• Establish and maintain a flexible resource-support model across Business Units for agreed workload peaks, absences and critical delivery periods.
• Assess EDC/CDMS platform readiness, system changes, migrations and standards-library opportunities, and coordinate recommendations with relevant system and process owners. Support practical technical decision-making across the EDC platforms used by TFS and future platforms adopted by the organisation.

Training, Competency and Workforce Development

• Define and maintain the DBP competency framework, training plan, onboarding pathway and technical career-development materials. Lead or coordinate technical training, mentoring, coaching and knowledge-sharing activities.
• Establish and maintain deputy, back-up, succession and business-continuity arrangements to reduce key-person dependency.
• Support workforce planning, role design, recruitment criteria, interview materials and technical assessment of DBP candidates.

Commercial, Proposal and Business Support

• Maintain standard DBP costing assumptions, proposal guidance and service descriptions in coordination with relevant commercial and operational stakeholders.
• Provide SME input for bid defence preparation or client discussions involving DBP capability, EDC platform readiness or database programming considerations.
• Promote sustainable handover, measurable benefits and continued adoption of agreed improvements.

Qualifications: 

• 10+ years’ relevant experience in database programming, clinical systems or clinical data operations within a CRO, pharmaceutical, biotechnology or clinical research environment, including experience operating at Principal Database Programmer, Senior Principal Database Programmer, DBP SME, Capability Lead or equivalent level.
• Significant direct technical knowledge and experience 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 supporting audits, inspections, CAPAs or quality improvement actions.
• Demonstrable experience developing or improving SOPs, Work Instructions, templates, standards, training materials or process documentation.
• Experience leading 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 manage an ongoing portfolio of capability, governance,
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