Global Clinical DBP Process Leader (Remote)

TFS HealthScience; Birmingham; À distance; GBP 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Competitive compensation package

Career development and growth

Résumé du poste

TFS HealthScience is seeking a Clinical Database Programming Process Lead to own the DBP capability strategy and operate across UK and Europe on a remote basis. The role combines governance, quality, and technical leadership to deliver scalable, compliant database programming solutions for global clinical studies.

You will drive standards, training, and continuous improvement, while supporting audits, inspections and complex issue resolution in a fast-paced CRO environment.

Qualifications

• 10+ years' relevant experience in database programming, clinical systems or clinical data operations within a CRO, pharmaceutical, biotechnology or clinical research environment.
• 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

Responsabilités

• 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.

Description du poste

TFS HealthScience is seeking a Clinical Database Programming Process Lead to own the DBP capability strategy and operate across UK and Europe on a remote basis. The role combines governance, quality, and technical leadership to deliver scalable, compliant database programming solutions for global clinical studies.

You will drive standards, training, and continuous improvement, while supporting audits, inspections and complex issue resolution in a fast-paced CRO environment.