Freelance Clinical Database Programming Process Lead

TFS HealthScience•Frankfurt, United Kingdom

3d•Remote

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

Develop and sustain a consistent, scalable and high-quality clinical database programming capability across TFS.
Conduct Database Programming (DBP) current-state capability and risk assessment.
Develop a DBP Capability Plan and prioritised improvement roadmap.
Establish a DBP governance model, including roles, responsibilities, escalation routes and cross-BU forum structure.
Track delivery of agreed roadmap, and manage risk to progress.
Review 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.
Develop a DBP knowledge repository and reusable standards/library structure.
Assess future EDC platform readiness and provide recommendations.
Provide targeted hands-on DBP support where needed to protect delivery.
Develop a DBP competency framework and training plan.
Create a DBP onboarding pathway for new hires and contractors.
Support recruitment criteria, interview assessment materials and technical evaluation of DBP candidates.
Develop a Deputy, backup and succession plan for DBP capability.
Support mentoring and coaching of DBP personnel and potential deputies.
Develop 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.
Define agreed quality and effectiveness measures for handover and sustainability.