Associate Director, Component Libraries, Evinova

Join Evinova to help transform digital clinical measurement at scale. We’re building world-class component libraries that power consistent, compliant, and efficient eCOA/COA delivery across global studies. We are now lokking for someone wo would like yto join us as an Associate Director, Component Libraries.

About the role
As Associate Director, Component Libraries, you will set the strategy, lead a small specialist team, and own the lifecycle of instrument configurations—driving standards, automation, and audit-ready quality.

In this role you will define and execute the technical vision for Evinova’s eCOA component libraries and future configuration libraries. Partnering across Science, Product, Platform, Commercial, and vendor teams, you’ll convert portfolio needs into scalable standards and capabilities that reduce cycle time, uphold data integrity, and ensure regulatory compliance.

Main accountabilities

• Library Strategy & Roadmap: Define the technical vision and multi‑year roadmap for the eCOA library and future configuration libraries, anchored in ambitious and measurable KPIs.
• Component Lifecycle Management: Own end‑to‑end lifecycle for instrument configurations; drive improvements with Product and Platform teams including CDISC alignment to raw data standards, instrument metadata and reference data discipline, and automation of component validation.
• Team Leadership & Study Support: Project manage a small team of eCOA librarians/analysts and matrixed contributors; consult with study and product teams, translate requirements, and ensure timely configuration delivery through standardized workflows.
• Risk & Issue Management: Proactively identify configuration and content risks and errors; run impact assessments and lead remediation across live studies and future builds. Enforce and evolve SOPs and quality controls to ensure compliance with 21 CFR Part 11, GCP, copyright, and audit readiness.
• Stakeholder Engagement & Collaboration: Build high‑quality, compliant, and efficient instrument processes through requirement gathering and close collaboration with internal and external partners across Science, Product, Commercial, and vendors.

Key competencies

• Technical Depth: Builds and troubleshoots instruments end to end with strong attention to detail and validation rigor.
• Strategic Thinking: Converts portfolio needs into scalable library standards and capabilities.
• Operational Excellence: Reduces cycle time and defects; drives CAPA effectiveness and audit readiness.
• Collaboration: Works effectively with clinical, biometrics, IT, Commercial, CMS, product, and vendor teams.
• Data & Standards Orientation: Enforces metadata discipline and raw data standards integration.
• Adaptability: Navigates evolving instruments, platform updates, and regulatory expectations.

Essential requirements

• Bachelor’s degree in a STEM field (engineering, computer science, life sciences, health informatics, biomedical engineering, or related). Advanced degree preferred.
• 6+ years in eCOA/COA/PRO operations, digital health, clinical data standards, or product/content management.
• Fluent in English and Swedish (spoken and written).
• Strong experience with technical solutions and specifically configuration of UTS.
• Strong knowledge of PRO/COA methodologies and platforms, instrument licensing, validation practices, and build workflows.
• Understanding of CDISC standards, metadata management, and scoring algorithms.
• Experience with 21 CFR Part 11, GCP, GDPR, and accessibility standards.
• Competence in structured documentation, process design, and basic API/vendor integration concepts.

Location and travel
Location: Gothenburg, Sweden. Periodic travel to vendors and study sites as needed.

Why Evinova
At Evinova, we seize opportunities for change. We push the boundaries of what a life sciences company can achieve through innovative digital solutions. Join us in shaping the future of digital health and be part of an interdisciplinary team that makes a tangible impact on health outcomes around the world.

So, what’s next?
If you’re motivated to operationalize standards, accelerate delivery, and improve data quality in digital clinical measurement, we’d like to hear from you. Please submit your CV and a short cover letter describing relevant experience in eCOA/COA and configuration library management.

Date Posted

28-nov.-2025

Closing Date

05-dec.-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.