Clinical Database Programming Process Lead
About this role
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 aClinical Database Programming Process Lead - home based in UK, Sweden, Germany, Spain, Portugal or Poland
About this role
As part of our CDSGroup Management (Operations) team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals.
The Clinical Database Programming Process Leadis 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 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. 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 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
Experience supporting EDC platform change, system migration, standards library development or process transformation.
Experience working in a mid-sized CRO and decentralised cross-BU operating model
What We Offer
We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
For candidates based in Spain - TFS is committed to equal opportunities. All our vacancies are open to people with disabilities, in accordance with the General Law on the Rights of Persons with Disabilities (Royal Legislative Decree 1/2013).
A Bit More About Us
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.
Together we make a difference.
Originally posted on Himalayas