Remote Freelance Clinical Database Programming Process Lead

TFS HealthScience

Barcelona

Presencial

EUR 70.000 - 120.000

Jornada completa

Hace 4 días
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Descripción de la vacante

TFS HealthScience seeks a Freelance Clinical Database Programming Process Lead to build and sustain a scalable DBP capability across a global CRO. You will drive governance, validation, testing and documentation while supporting audits and platform readiness.

The role offers remote work options with international scope and requires extensive DBP expertise. The position emphasizes delivering hands-on support, mentoring DBP staff, and shaping competency frameworks for ongoing capability growth

Formación

  • 5–10 years database programming experience in a CRO, pharmaceutical or clinical research environment.
  • Strong technical knowledge of clinical database build, validation, edit checks, data transfer programming, database lock and EDC study setup 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.

Responsabilidades

  • Develop and sustain a consistent, scalable and high-quality clinical database programming capability across TFS.
  • Deliver a capability roadmap, governance model and cross-BU collaboration structure for DBP.
  • Review SOPs, templates and quality trends; propose improvements and change recommendations.
  • Support audits and inspections where DBP expertise is required.
  • Act as senior DBP technical escalation point for complex, high-risk issues and provide hands-on support when needed.
  • Create a DBP competency framework, onboarding pathways and training plans.
  • Provide commercial and proposal input for DBP services and ensure agreed quality measures are met.

Conocimientos

DBP experience
EDC/CDMS platforms
GxP knowledge
Cross-functional collaboration
Technical training/mentoring

Descripción del empleo

TFS HealthScience seeks a Freelance Clinical Database Programming Process Lead to build and sustain a scalable DBP capability across a global CRO. You will drive governance, validation, testing and documentation while supporting audits and platform readiness.

The role offers remote work options with international scope and requires extensive DBP expertise. The position emphasizes delivering hands-on support, mentoring DBP staff, and shaping competency frameworks for ongoing capability growth

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