Remote Senior Clinical Database Programming Lead

TFS HealthScience; United Kingdom; Remote; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Competitive compensation package

Global opportunities and growth

Equal opportunities (Spain)

Job summary

TFS HealthScience is recruiting a Clinical Database Programming Process Lead to own strategy and development of a scalable, high-quality DBP capability. This home-based role supports UK, Sweden, Germany, Spain, Portugal or Poland, with international cross-BU collaboration.

You will lead governance, quality, and continuous improvement while providing senior technical guidance across global units. The role emphasizes change management, SOP development and capable leadership.

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, improvement and operational-support priorities

Responsibilities

• 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.
• 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.
• 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.

Job description

TFS HealthScience is recruiting a Clinical Database Programming Process Lead to own strategy and development of a scalable, high-quality DBP capability. This home-based role supports UK, Sweden, Germany, Spain, Portugal or Poland, with international cross-BU collaboration.

You will lead governance, quality, and continuous improvement while providing senior technical guidance across global units. The role emphasizes change management, SOP development and capable leadership.