Director, eCOA Licensing and Localization - Evinova (Remote)
Role Overview
We are seeking an experienced and strategic Director, eCOA Licensing and Localization to lead our eCOA shared services domain. This is a senior leadership role accountable for the people, performance, and output of the teams responsible for eCOA configuration, instrument licensing, localization, and screenshot production.
Responsibilities
Team Leadership & People Management: Own the day-to-day management of the teams across the eCOA shared services domain, including resourcing, workload prioritization, performance management, coaching, and career development. Build a high-performing, collaborative culture focused on quality and continuous improvement.
eCOA Build & Instrument Licensing: Maintain hands-on fluency with eCOA/ePRO build and configuration, and own the end-to-end instrument licensing process, including intake, ownership identification, fee tracking, and copyright approvals across a global study portfolio.
Licensing Partner Relationships: Establish and run Evinova's licensing function on a study-by-study basis, owning and growing commercial relationships with instrument licensing partners, negotiating terms and resolving escalations directly.
Localization & Translation Management: Own the end-to-end multilingual localization workflow for studies, from scoping language requirements by country through translation, linguistic validation (LV), and deployment-ready sign-off.
Translation Partner Relationships: Own and grow Evinova's commercial relationships with translation and localization partners, setting service expectations and managing performance against agreed timelines and quality standards.
Screenshot Production & Submission Readiness: Own the process, quality, and production of screenshot packages across source language and all localized versions, ensuring version-controlled archives remain audit-ready and suitable for regulatory submission.
Product Collaboration: Partner closely with the Product team to shape the tooling that supports eCOA build and configuration, screenshot production, and translation/localization workflows. Share team feedback and delivery insight to inform the product roadmap, and drive adoption of new tooling and capabilities across the team.
Sales & Feasibility Partnership: Partner with the Sales/Commercial team to support feasibility assessments for new and prospective studies, providing clear, timely guidance on licensing timelines, localization scope, and delivery feasibility to support accurate scoping, proposals, and customer commitments.
Customer-Facing Engagement: Act as Evinova's senior eCOA subject matter expert in sponsor- and CRO-facing forums, including senior governance and escalation discussions, translating complex requirements into clear delivery commitments.
Resource Allocation & Prioritization: Determine team priorities in alignment with portfolio and business needs, and allocate resources to meet delivery commitments and quality standards across a growing book of work.
Process & Best Practice: Identify opportunities to improve eCOA licensing, localization, and screenshot processes, and drive adoption of best practices and reuse across the team.
Risk Management: Proactively identify licensing, localization, and screenshot risks across the team's portfolio of studies (e.g., late licenses, unexpected language scope, LV gaps) and put mitigation plans in place through the project RAID framework.
Metrics & Reporting: Establish and maintain reporting on team performance, delivery progress, and quality, and use it to inform decisions on resourcing and prioritization.
Cross-Functional Leadership: Represent the eCOA shared services function in discussions with Delivery leadership, Product, and Commercial, and act as a key partner in shaping strategy across those functions.
Qualifications
eCOA Vendor Experience: Must have prior experience in an equivalent role at another eCOA vendor, owning the same end-to-end eCOA licensing and localization function.
Instrument Licensing Expertise: Must have extensive, hands-on experience across the full range of eCOA/ePRO instrument types and licensing models, with a demonstrated ability to build and run a licensing function or service from the ground up.
Localization at Scale: Must have deep experience managing eCOA localization at scale — multilingual builds, translation vendor relationships, linguistic validation evidence, and language-specific instrument license approvals.
Independent Problem-Solving: Must be able to operate independently amid ambiguity and competing priorities across licensing, localization, and delivery timelines, driving issues to resolution without needing significant direction, and staying effective and level-headed when the path forward isn't clear-cut.
Proven experience leading and managing multi-disciplinary teams responsible for eCOA configuration, licensing, localization, and/or screenshot production, including resourcing and prioritization at a portfolio level.
Track record owning commercial relationships with licensing and/or translation partners, including negotiation and performance management.
Senior, direct customer-facing experience in a clinical technology delivery environment — comfortable leading sponsor and CRO governance discussions and representing the business as an external SME.
Strong command of eCOA/ePRO instrument licensing and copyright requirements, including instrument owner screenshot review and approval processes.
Experience partnering with Sales/Commercial teams on licensing and delivery feasibility, scoping, or pre-sales support for new studies.
Additional Qualifications
Familiarity with eCOA regulatory guidance: FDA PRO guidance, EMA qualification opinions, ISPOR standards, and cross-cultural instrument adaptation requirements.
Experience with decentralized or hybrid clinical trial models and multimodal eCOA deployments (BYOD, web, provisioned device).
Knowledge of clinical data standards (CDASH, CDISC) and EDC integrations as they relate to eCOA outputs.
Experience setting up or scaling a licensing or vendor-management function within a clinical technology or life sciences business.
Experience partnering with Product teams to influence tooling and platform roadmap based on delivery and customer insight.