Clinical Database Programming Process Lead

TFS HealthScience • Frankfurt, United Kingdom

13h • Remote

About The Position

The Clinical Database Programming Process Lead owns the strategy, development and ongoing improvement of a consistent, scalable and high-quality clinical database programming (DBP) capability across TFS. The position is part of the CDS Group Management (Operations) team and combines enterprise subject matter expertise and capability ownership with governance, quality and continuous-improvement leadership, as well as senior technical and operational support to Business Units. Business Units remain accountable for study delivery and local resource management.

The role leads capability planning and the DBP operating model, maintains enterprise standards and controlled documentation, and supports quality, compliance and inspection readiness. It serves as a senior technical escalation point for complex DBP issues and provides targeted hands-on support when needed. The position also develops training and workforce capabilities, supports commercial proposals and client discussions, and promotes adoption of improvements across the organization.

The position is home based in the UK, Sweden, Germany, Spain, Portugal or Poland. TFS describes itself as a global, full-service CRO with over 600 professionals, serving more than 50 countries.

Requirements

• At least 10 years of relevant experience in database programming, clinical systems or clinical data operations within a CRO, pharmaceutical, biotechnology or clinical research environment.
• Experience 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 and 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 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, including the ability to translate technical DBP issues into practical business recommendations.
• Ability to manage an ongoing portfolio of capability, governance, improvement and operational-support priorities.

Nice To Haves

• Experience supporting EDC platform change, system migration, standards library development or process transformation.
• Experience working in a mid-sized CRO and decentralised cross-Business-Unit operating model.

Responsibilities

• Develop, maintain and deliver the Database Programming capability plan and prioritised improvement roadmap.
• Own and continually improve the DBP governance and operating model, including roles, responsibilities, decision rights, escalation routes and cross-Business-Unit forums.
• Maintain enterprise standards, playbooks, templates, tools, reusable libraries and the DBP knowledge repository.
• 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.
• Serve as senior DBP technical escalation point for complex, high-risk or strategically important issues.
• Provide targeted hands-on support 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 TFS EDC platforms and future platforms adopted by the organization.
• 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.
• Maintain standard DBP costing assumptions, proposal guidance and service descriptions 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.

Benefits

• Competitive compensation package.
• Comprehensive benefits.
• Opportunity for personal and professional growth.
• Collaborative and innovative working environment focused on making a difference in patients’ lives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed