Clinical Database Programming Lead

This is a fully remote position, open to applicants in United Kingdom, +5 more countries.

📋 Description

• Develop, manage, and execute the Database Programming capability plan along with a prioritized improvement roadmap.

• Take ownership of and enhance the DBP governance and operational framework, which includes defining roles, responsibilities, decision-making authority, escalation paths, and cross-BU forums.

• Uphold enterprise standards, playbooks, templates, tools, reusable libraries, and the DBP knowledge base.

• Serve as the process owner or designated Subject Matter Expert (SME) for relevant global Standard Operating Procedures (SOPs), Work Instructions, templates, and controlled documents.

• Track quality trends, recurring issues, Corrective and Preventive Actions (CAPAs), and systemic risks, leading effective, risk-based improvement initiatives.

• Encourage the consistent application of validation, testing, change control, documentation, database construction, and database lock requirements.

• Offer DBP expertise during audits, inspections, client assessments, and remediation efforts.

• Act as the senior technical escalation point for intricate, high-risk, or strategically significant matters.

• Provide focused, hands-on support to safeguard delivery, address priority challenges, or fill short-term capability gaps.

• Create and uphold a flexible resource-support model across Business Units.

• Evaluate EDC/CDMS platform readiness, system changes, migrations, and opportunities within the standards library.

• Assist in technical decision-making for current and future EDC platforms.

• Define and uphold the DBP competency framework, training strategy, onboarding process, and technical career development resources.

• Lead or coordinate technical training, mentoring, coaching, and knowledge-sharing sessions.

• Establish deputy, backup, succession, and business continuity plans.

• Aid in workforce planning, role design, recruitment criteria, interview materials, and the technical evaluation of DBP candidates.

• Maintain standard DBP costing assumptions, proposal guidelines, and service descriptions.

• Provide SME insights for bid defense preparations or client interactions.

• Advocate for sustainable handovers, measurable benefits, and the adoption of agreed-upon improvements.

⛳️ Requirements

• Over 10 years of relevant experience in database programming, clinical systems, or clinical data operations within a CRO, pharmaceutical, biotechnology, or clinical research setting.

• Experience at the level of Principal Database Programmer, Senior Principal Database Programmer, DBP SME, Capability Lead, or an equivalent role.

• Extensive direct technical knowledge and experience with clinical database construction, validation, edit checks, data transfer programming, database locking, and EDC study setup processes.

• Familiarity with one or more major EDC/CDMS platforms and the capability to operate across multiple systems.

• Strong comprehension of GxP expectations related to clinical systems, database programming, validation, testing, documentation, and inspection readiness.

• Experience in supporting audits, inspections, CAPAs, or quality enhancement initiatives.

• Proven experience in developing or refining SOPs, Work Instructions, templates, standards, training materials, or process documentation.

• Experience in leading technical training, mentoring, or coaching efforts for database programming personnel.

• Ability to collaborate across various Business Units and stakeholder groups without direct line authority.

• Strong analytical, problem-solving, and practical risk-based decision-making abilities.

• Excellent written and verbal communication skills, with the capability to translate technical DBP challenges into actionable business recommendations.

• Ability to manage an ongoing portfolio of capabilities, governance, improvement, and operational support priorities.

• Preferred: experience with EDC platform changes, system migrations, standards library development, or process transformation.

• Preferred: experience in a mid-sized CRO and a decentralized cross-BU operational model.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional development.

• A collaborative, innovative, and rewarding work environment.