TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Clinical Database Programming Process Lead - home based in UK, Sweden, Germany, Spain, Portugal or Poland

About this role

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 Clinical Database Programming Process Lead is responsible for the ongoing ownership, strategy, and development of a consistent, scalable and high-quality clinical database programming capability across TFS.

The role combines:

(1) enterprise subject matter expertise and capability ownership;

(2) governance,quality and continuous improvement leadership;

(3) senior technical and operational support across Business Units for complex issues, strategic priorities and agreed capacity gaps. Business Units retain accountability for study delivery and local resource management.

What Will Make You Successful in This Role?

Success in this role requires a strong combination of deep hands-on clinical database programming experience, strategy and change management, as well as leadership. You will be able to assess complex technical and operational challenges, provide pragmatic, compliant, risk-based recommendations and build productive relationships across Business Units and global stakeholder groups.

You will bring credibility as a senior technical expert, who drives consistent standards, quality, cost and service definitions, capability development and continuous improvement. You will be comfortable leading with influence, communicating complex matters clearly,



and applying technical expertise to drive change and action.

Key Responsibilities:

Capability and Process Ownership

- 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 versátil 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

📌 Clinical Database Programming Process Lead (Barcelona)
🏢 TFS HealthScience
📍 Barcelona