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. Join Our Team as a Freelance Clinical Database Programming Process Lead (1.0 FTE) - home based in UK, Germany, Poland, Portugal, Spain or office based in Sweden.
The Freelance Clinical Database Programming Process Lead is responsible for developing and sustaining a consistent, scalable and high-quality clinical database programming capability across TFS. Database Programming (DBP) current-state capability and risk assessment.
Track delivery of agreed roadmap, and manage risk to progress
Quality, Compliance and Inspection Readiness
Review of relevant SOPs, Work Instructions, templates and controlled documents, with efficiency, compliance and alignment change recommendations.
Review quality trends, systemic risks and improvements
Support consistent application of validation, testing, change control, documentation and database build activities
Support or prepare for audits and inspections where DBP process expertise required
Act as senior DBP technical escalation point for complex, high-risk or strategically important DBP issues
Training, Competency and Workforce Development
DBP competency framework and training plan.
DBP onboarding pathway for new hires and contractors. Support mentoring and coaching of DBP personnel and potential deputies.
Commercial, Proposal and Business Support
Provide SME input for bid defence preparation or client discussions involving DBP capability, EDC platform readiness or database programming considerations.
Agreed quality and effectiveness measures for handover and sustainability.
Experience operating at Principal Database Programmer, Senior Principal Database Programmer, DBP SME, Capability Lead or equivalent level.
Experience supporting audits, inspections, CAPAs or quality improvement actions.
Experience developing competency frameworks, onboarding pathways, training programmes or technical career progression materials.
Experience supporting proposals, bid defences, costing assumptions or commercial input for DBP services.
Experience supporting EDC platform change, system migration, standards library development or process transformation.
5 - 10 years database programming experience in a CRO, pharmaceutical, biotechnology or clinical research environment.
~ Strong technical knowledge of clinical database build, validation, edit checks, data transfer programming, database lock and EDC study set-up processes.
~ Strong understanding of GxP expectations relevant to clinical systems, database programming, validation, testing, documentation and inspection readiness.
~ Experience developing or improving SOPs, Work Instructions, templates, standards, training materials or process documentation.
~ Experience providing 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 work independently and deliver structured outputs within a fixed-term assignment.
We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. 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.
Remote Freelance Clinical Database Programming Process Lead in Clophill employer: TFS HealthScience
TFS HealthScience is an exceptional employer, offering a dynamic and supportive work environment that prioritises collaboration and innovation. With a strong commitment to employee growth, we provide comprehensive benefits and opportunities for professional development, ensuring that our team members can thrive in their careers while making a meaningful impact in the clinical research field. Join us in our mission to improve patient lives, where your contributions are valued and recognised within a culture built on trust and excellence.
