Director, eCOA Licensing and Localization

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the daily management of teams within the eCOA shared services domain, which encompasses resource allocation, workload prioritization, performance management, coaching, and career development.

• Foster a high-performing and collaborative culture that prioritizes quality and continuous improvement.

• Maintain active proficiency in eCOA/ePRO build and configuration, managing the complete instrument licensing process, including intake, ownership identification, fee tracking, and copyright approvals across a global study portfolio.

• Establish and operate Evinova's licensing function for each study, cultivating and enhancing commercial relationships with instrument licensing partners, negotiating terms, and addressing escalations directly.

• Manage the comprehensive multilingual localization workflow for studies, from identifying language requirements by country to translation, linguistic validation (LV), and obtaining deployment-ready sign-off.

• Develop and strengthen Evinova's commercial relationships with translation and localization partners, setting service expectations, and overseeing performance against established timelines and quality benchmarks.

• Oversee the process, quality, and production of screenshot packages across source languages and all localized versions, ensuring version-controlled archives are audit-ready and suitable for regulatory submission.

• Collaborate closely with the Product team to influence the tools that support eCOA build and configuration, screenshot production, and translation/localization workflows.

• Work alongside the Sales/Commercial team to assist in feasibility assessments for new and prospective studies, providing timely and clear guidance on licensing timelines, localization scope, and delivery feasibility to ensure accurate scoping, proposals, and customer commitments.

• 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 straightforward delivery commitments.

• Determine team priorities in line with portfolio and business needs, allocating resources to meet delivery commitments and maintain quality standards across an expanding workload.

• Identify opportunities to enhance eCOA licensing, localization, and screenshot processes, promoting the adoption of best practices and reuse within the team.

• Proactively recognize risks associated with licensing, localization, and screenshots across the team’s portfolio of studies (e.g., late licenses, unexpected language scope, LV gaps) and implement mitigation plans through the project RAID framework.

• Establish and maintain performance reporting on team effectiveness, delivery progress, and quality, using this data to inform decisions on resource allocation and prioritization.

• Represent the eCOA shared services function in discussions with Delivery leadership, Product, and Commercial, acting as a vital partner in shaping strategies across these functions.

⛳️ Requirements

• eCOA Vendor Experience: Must possess prior experience in a similar role within another eCOA vendor, managing the complete eCOA licensing and localization functions.

• Instrument Licensing Expertise: Must demonstrate extensive hands-on experience across the full spectrum of eCOA/ePRO instrument types and licensing models, with a proven ability to establish and manage a licensing function or service from the ground up.

• Localization at Scale: Must have significant experience in managing eCOA localization at scale, including multilingual builds, translation vendor relationships, linguistic validation evidence, and language-specific instrument license approvals.

• Independent Problem-Solving: Must be capable of working independently in ambiguous situations and competing priorities across licensing, localization, and delivery timelines, resolving issues without extensive direction, while maintaining composure when the path forward is not straightforward.

• Proven experience in leading and managing multi-disciplinary teams responsible for eCOA configuration, licensing, localization, and/or screenshot production, including resource allocation and prioritization at a portfolio level.

• Successful track record in managing commercial relationships with licensing and/or translation partners, including negotiation and performance oversight.

• 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 subject matter expert.

• Strong understanding of eCOA/ePRO instrument licensing and copyright regulations, including processes for instrument owner screenshot review and approval.

• Experience in collaborating with Sales/Commercial teams on licensing and delivery feasibility, scoping, or pre-sales support for new studies.

🏝️ Benefits

• Short-term incentive bonus opportunity.

• Eligibility to participate in our equity-based long-term incentive program.

• Qualified retirement program [401(k) plan].

• Paid vacation and holidays.

• Paid leaves.

• Health benefits including medical, prescription drug, dental, and vision coverage.