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 a Freelance Clinical Database Programming Process Lead (1.0 FTE) - home based in UK, Germany, Poland, Portugal, Spain or office based in Sweden.
About this role
As part of our CDS Group Management (Operations) team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals.
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.
Key Responsibilities:
The role should be outcome-based, with expected deliverables agreed at start-up.
Key Deliverables:
Capability Assessment and Improvement Roadmap
Database Programming (DBP) current-state capability and risk assessment.
DBP Capability Plan and prioritised improvement roadmap.
DBP governance model, including roles, responsibilities, escalation routes and cross-BU forum structure.
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
Technical Leadership and Escalation Support
Act as senior DBP technical escalation point for complex, high-risk or strategically important DBP issues
DBP knowledge repository and reusable standards/library structure.
Future EDC platform readiness assessment and recommendations.
Provide targeted hands-on DBP support where needed to protect delivery
Training, Competency and Workforce Development
DBP competency framework and training plan.
DBP onboarding pathway for new hires and contractors. Support recruitment criteria, interview assessment materials and technical evaluation of DBP candidates.
Deputy, backup and succession plan for DBP capability.
Support mentoring and coaching of DBP personnel and potential deputies.
Commercial, Proposal and Business Support
Standard DBP costing/proposal assumptions and sales support guidance.
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.
Preferred Experience
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 with EDC platforms relevant to TFS.
Experience supporting EDC platform change, system migration, standards library development or process transformation.
Experience in a mid-sized CRO environment
Qualifications:
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.
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 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.
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
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.
