Director, Registry Operations

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

📋 Description

• Act as the empowered operational leader for the CHORUS and HHT Connect registries.

• Provide strategic vision and daily oversight, driving execution of a multi-year CHORUS roadmap.

• Reconstruct and uphold registry governance frameworks, committees, policies, SOPs, charters, and data-sharing processes.

• Organize and facilitate Steering Committee and governance meetings, including preparing agendas, materials, minutes, decisions, follow-ups, and document version control.

• Oversee IRB communications, submissions, approvals, amendments, and regulatory documentation that is audit-ready across participating sites.

• Maintain regulatory compliance and participant confidentiality, incorporating data tokenization and de-identification workflows.

• Coordinate site documentation, disclosures of interest, and approvals for manuscript and data use reviews.

• Serve as the primary contact for data access requests, clarifying data needs with researchers and project sponsors.

• Create, negotiate, and finalize data use agreements while managing the DUA pipeline.

• Implement a transparent data access and sharing model, including a fee structure.

• Lead regular Data Analytics meetings.

• Manage research data delivery schedules, standardized exports, quality assurance reviews, secure sharing sites, permissions, dataset lifecycles, communications, and archiving.

• Generate quarterly registry reports and assist with government reporting and grant renewals.

• Handle first-pass analytics until the Data Scientist / Registry Analytics Lead is appointed.

• Manage the Studytrax vendor relationship, including contract/scope, support tickets, and roadmap.

• Optimize Studytrax forms, workflows, and reporting while evaluating complementary tools.

• Oversee Studytrax database configuration and reporting, implementing validation and QA protocols.

• Supervise liaison activities with HHT Centers of Excellence, academic investigators, and the physician/research community.

• Coordinate registry participation, onboarding, engagement, scientific work, manuscript and data review, and multi-site operations.

• Develop participant recruitment and enrollment strategies, set targets, drive campaigns, track the enrollment funnel, and implement retention strategies.

• Provide registry-enabled recruitment support for Clinical Trial Network partners.

• Act as the registry point of contact for CTN partners and sponsors, managing governed data handoffs.

• Deliver standardized de-identified exports and quarterly reports to partners.

• Define project scope, goals, deliverables, resources, and metrics, ensuring cross-functional delivery.

• Identify and manage risks, issues, and dependencies while implementing mitigation strategies.

• Utilize approved AI tools such as Claude Cowork for documentation, meeting notes, and first-pass materials subject to human review.

⛳️ Requirements

• Bachelor’s degree or higher in a health or social science, or a related field, or an equivalent combination of education and experience.

• 3–5+ years of relevant experience in research study or similar fields.

• Proven experience as a project manager overseeing research, regulatory, and/or grant-funded initiatives.

• Background in multi-site clinical trials, regulatory compliance, data analytics, and operational exposure.

• Practical, hands-on experience with patient registries; experience with rare disease registries is strongly preferred.

• Comprehensive full-time registry operations experience.

• Direct experience interacting with academic centers, investigators, and/or clinical sites.

• Experience managing recruitment/enrollment and collaborating directly with researchers on agreement-based data deliverables.

• Experience overseeing a data-system vendor or platform; clinical data system experience is required.

• Familiarity with IRB processes, data use agreements, and research governance and compliance.

• Ability to lead without formal authority and operate independently in a remote setting.

• Strong written and verbal communication skills, attention to detail, time management, and problem-solving abilities.

• Comfort in developing new procedures.

• Basic computer proficiency and familiarity with project management tools and methodologies.

• Willingness to complete CITI training prior to engaging with participants and to recertify every three years.

• Previous experience establishing or revitalizing a registry’s governance, data access, and data-sharing framework is preferred.

• Familiarity with rare disease registry models and best practices is preferred.

• Experience preparing data and reports for federal funders and grant renewals is preferred.

• Experience collaborating with industry/pharma partners under governed data-sharing agreements is preferred.

• Comfort with adopting AI-assisted workflows within defined governance guardrails is preferred.

🏝️ Benefits

• Comprehensive benefits package.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Generous PTO.

• Remote work opportunities.

• Professional development opportunities.