Clinical Database Programming Lead

🔥 1 minute ago

🌐 United Kingdom, Sweden, +4 more countries – Remote

🇬🇧 United Kingdom – Remote 🇸🇪 Sweden – Remote 🇩🇪 Germany – Remote 🇪🇸 Spain – Remote 🇵🇹 Portugal – Remote 🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• 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 • 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 • Act 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 • Assess EDC/CDMS platform readiness, system changes, migrations and standards-library opportunities • Support technical decision-making across current and future EDC platforms • 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 deputy, back-up, succession and business-continuity arrangements • 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 • Provide SME input for bid defence preparation or client discussions • Promote sustainable handover, measurable benefits and adoption of agreed improvements

🎯 Requirements

• 10+ years’ relevant experience in database programming, clinical systems or clinical data operations within a CRO, pharmaceutical, biotechnology or clinical research environment • 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 • Preferred: experience supporting EDC platform change, system migration, standards library development or process transformation • Preferred: experience working in a mid-sized CRO and decentralised cross-BU operating model

🏖️ Benefits

• Competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth • Collaborative, innovative and rewarding work environment