Associate Director, eCOA Licensing and Localization Evinova
Durham, NC - USA
Job Summary
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 Evinovas Unified Trial Solution (UTS). In this role you own the endtoend processes and lead the teams responsible for eCOA configuration instrument licensing localization and screenshot production - ensuring highquality 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 Evinovas structured study delivery model from project kick-off through to database lock and study close-out.
Key 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 Evinovas 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 Evinovas 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 Evinovas 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 Evinovas 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 Evinovas eCOA delivery methodology
Plan work and resourcing to ensure delivery to agreed timelines
Build a can-do collaborative culture
What We Are Looking For:
Essential Skills and Experience:
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.
Desirable
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.
SO WHATS NEXT
To be considered for this exciting opportunity please complete the full application on our website at your earliest convenience it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit please share this posting with them.
Where can I find out more
- Explore what were building:
- Stay connected and see our impact in action: today to bring smarter faster clinical trials to life!
Evinova is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. Evinova is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment assessment and selection process and may be requested by emailing.
#LI-Hybrid
The annual base pay for this position ranges from $124000.00 - $163170.00 pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and experience.
In addition our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program. 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.
Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired employee will be in an at-will position and the Company reserves the right to modify base pay(as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.
Date Posted
16-Apr-2026Closing Date
26-Apr-2026Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and furtherance of that mission we welcome and consider applications from all qualified candidates regardless of their protected characteristics. If you have a disability or special need that requires accommodation please complete the corresponding section in the application form.
Required Experience:
Director
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more