Associate Director, eCOA Licensing and Localization

AstraZeneca • Durham, NC

5d • Hybrid

About The Position

WHY JOIN US? 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. Operating at the intersection of healthcare, technology, data, and analytics, we are helping unlock the full potential of digital health, transforming how clinical research is conducted, how care is delivered, and how patients experience healthcare. Our solutions are built to scale, driving efficiency, improving decision-making, and ultimately delivering better outcomes for patients worldwide. 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. We also recognize the importance of flexibility and balance. Our ways of working support both individual needs and team collaboration. To foster connection and collaboration, employees are expected to work from the office three days per week, creating opportunities for in-person teamwork, innovation, and meaningful connection. About the Role: Deployed across 50+ countries and 115+ language locales, eCOA sits at the core of every study delivered on Evinova’s Unified Trial Solution (UTS). In this role, you own the end‑to‑end processes and lead the teams responsible for eCOA configuration, instrument licensing, localization, and screenshot production - ensuring high‑quality, compliant delivery at scale. This is also a customer-facing role. You will be the eCOA expert across sponsor and CRO portfolios and governance forums, translating complex technical detail into clear, confident delivery discussions. You will work alongside Project Managers, Configuration Engineers, and Content Managers as part of Evinova's structured study delivery model, from project kick-off through to database lock and study close-out.

Requirements

• Hands-on experience configuring and building eCOA or ePRO studies — comfortable operating platform tooling to set up instruments and branching logic
• Proven experience managing eCOA localization: managing multilingual builds, translation workflows, linguistic validation evidence, and language-specific instrument licence approvals.
• Proven experience producing eCOA screenshots using tooling - with precision around layout compliance, version control, and instrument owner approval cycles.
• Direct customer-facing experience in a clinical technology delivery role: comfortable leading sponsor meetings, managing stakeholder expectations, and articulating technical decisions clearly.
• Strong understanding of COA/PRO instrument licensing and copyright requirements, including the instrument owner screenshot review and approval process.
• Solid grasp of the clinical trial lifecycle and where eCOA build and localization create delivery risk if not managed proactively.
• Experience in leading and managing teams responsible for producing eCOA and localization related deliverables.

Nice To Haves

• 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.

Responsibilities

• eCOA Study Build & Instrument Licensing Lead the team responsible for configuring eCOA instruments at study level within the UTS platform, translating protocol requirements and CRFs into accurate, validated builds — covering ePRO, eClinRO, ObsRO, and custom assessments.
• Manage COA/PRO instrument licensing end-to-end: identifying instrument ownership, securing licences for all countries and languages, coordinating copyright approvals, and tracking fees across a portfolio of studies.
• Serve as a SME for maintaining Evinova's eCOA instrument library, maximizing reuse of pre-validated assessments to accelerate study start-up.
• Localization & Translation Management Lead the teams responsible for delivering localization deliverables and own the end-to-end eCOA localization process. This includes scoping language requirements by country, coordinating translations with vendors, managing linguistic validation (LV) evidence, and ensuring all localized instruments are approved and deployment-ready.
• Operate Evinova's localization tooling to manage translation imports, string reviews, and localized builds.
• Secure country and language-specific instrument licences and approval from instrument developers for each localized version, managing review cycles to agreed timelines.
• Maintain Evinova's multilingual content library, capturing validated translations for reuse across studies and reducing repeated licensing and translation effort.
• Track localization milestones within the study plan, flagging risks (late licences, unexpected language scope, LV gaps) early through the project RAID framework.
• Screenshot Production & Tooling Own the process, quality, and production of screenshot packages - both source language and all localized versions.
• Manage screenshot review and approval cycles with instrument owners, translation vendors, and sponsor representatives to agreed SLAs.
• Maintain version-controlled screenshot archives that are audit-ready, amendment-aligned, and suitable for regulatory submission.
• Continuously improve screenshot tooling processes to reduce turnaround times.
• Customer-Facing Delivery Serve as Evinova's eCOA SME in sponsor and CRO-facing forums. Translate complex eCOA and localization requirements into clear build specifications and delivery timelines, raising risks early and proposing mitigations.
• Work closely with the Project Manager to ensure eCOA and localization milestones are integrated into the overall study delivery plan, scope, and change order process.
• Contribute to site and patient readiness by providing accurate, country-specific eCOA training and onboarding materials.
• Team Leadership and Management Lead, manage and coach the teams involved in the eCOA shared services domain and mature Evinova’s eCOA delivery methodology
• Plan work and resourcing to ensure delivery to agreed timelines
• Build a can-do, collaborative culture

Benefits

• Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees