AstraZeneca

Director, eCOA Licensing and Localization - Evinova (Remote)

US · Director

Sponsorship not specified$150k-$197kDetected 1 day ago

Product ManagementProduct StrategyNegotiationPerformance ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCollaborationProblem SolvingMentoring

About the role

This is a highly visible, customer-facing role.

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.

Requirements

Required (Must-Have)
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.
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.
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.
Must have prior experience in an equivalent role at another eCOA vendor, owning the same end-to-end eCOA licensing and localization function.
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.
Must have deep experience managing eCOA localization at scale - multilingual builds, translation vendor relationships, linguistic validation evidence, and language-specific instrument license approvals.
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.
Track record owning commercial relationships with licensing and/or translation partners, including negotiation and performance management.
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.

Nice to have

Familiarity with eCOA regulatory guidance: FDA PRO guidance, EMA qualification opinions, ISPOR standards, and cross-cultural instrument adaptation requirements.
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.
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Compensation

The annual base pay for this position ranges from $ 149,805.60 - $196,619.85 USD.

Benefits

Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.
Evinova is a health-tech business focused on accelerating better health outcomes by advancing digital transformation across the life sciences sector.
By combining science-based expertise, evidence-led rigor, and deep human insight, we design digital solutions that enable healthcare to work better for everyone.
At Evinova, we are driven by a shared purpose to transform health through data and digital innovation.
Our teams collaborate across disciplines to solve complex challenges, continuously learning and evolving in a fast-paced, high-impact environment.
Bachelor's degree in Life Sciences, Health Informatics, or a related field.

Equal opportunity

If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination.
Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

Visa & Work Authorization

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.

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This listing is sourced directly from AstraZeneca's careers page and normalized into a canonical job model.