Freelance Clinical Database Programming Process Lead
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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.
What Will Make You Successful in This Assignment?
While deep clinical database programming expertise is essential, this role is equally about influence, alignment and change leadership. Success will depend on your ability to communicate with confidence, clarity and credibility across multiple stakeholder groups.
You will be expected to assess complex technical and operational challenges, develop pragmatic recommendations and gain buy-in from senior leaders, functional experts and operational teams. The ideal candidate can translate technical database programming concepts into concise, business-focused messages that drive understanding, decision-making and action.
This is not a purely technical specialist role. We are looking for someone who can combine subject matter expertise with strong strategic communication, stakeholder engagement and the ability to influence change across a global organisation.
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
Present findings, recommendations and progress updates to senior stakeholders in a clear, concise and action-oriented manner, securing alignment and commitment to change initiatives.
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
Communication, Influence and Change Leadership
Lead discussions with senior stakeholders across Business Units to build alignment on capability, process and quality improvements.
Communicate complex technical and operational topics with clarity, confidence and appropriate level of detail for different audiences.
Challenge constructively and influence decision-making through data-driven recommendations and sound judgement.
Build credibility and trust across global teams to enable adoption of new processes, standards and ways of working.
Facili
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