Enterprise Solutions & Study Operations Lead

CRIO (Clinical Research IO) is a health tech company helping pharma, biotech, research sites, and academic research centers streamline regulatory workflows with one system and a single source of clinical data capture. Our modules allow sites to capture data electronically in real-time, providing data managers and monitors with enhanced transparency, and enabling remote monitoring by sponsors and CROs. CRIO’s eSource and CTMS system is a leading, modern, enterprise platform built for clinical research sites. Since CRIO’s launch in 2016, CRIO has established the leading brand position in eSource and has won close to 50% of the emerging class of enterprise‑grade site networks, many of whom are backed by institutional investors such as VC, PE and corporations. CRIO has achieved the attached metrics, all with little to no serious outbound sales or marketing. Position Summary The Enterprise Solutions & Study Operations Lead is a senior individual contributor serving as the operational and strategic backbone of CRIO’s Central eSource sponsor programs. This role combines the deep operational discipline needed to manage multi‑study sponsor portfolios with the technical fluency and stakeholder leadership required to architect and deliver complex integrations - from study design through go‑live. Positioned at the intersection of sponsor relationship management, cross‑functional orchestration, and eSource operational excellence, this person ensures that every Central eSource engagement moves forward with clarity, consistency, and accountability. They serve as the primary senior contact for sponsor organizations, the operational lead for internal study teams, and the connective tissue between product, engineering, study design, and client success. The ideal candidate brings both the structured thinking of a seasoned data manager and the technical depth to engage meaningfully on integration architecture, EDC mapping, and regulatory data standards. They build the playbooks, hold the accountability, and raise the bar for how CRIO delivers at scale. Key Responsibilities Sponsor Engagement & Relationship Management Serve as the primary point of contact and trusted advisor for sponsor organizations throughout the Central eSource project lifecycle. Lead structured discovery and requirements‑gathering sessions with sponsor stakeholders to define project scope, workflow expectations, and integration requirements. Drive ongoing sponsor discussions to surface change requirements, resolve blockers, and maintain project momentum. Proactively identify when sponsor decisions require escalation and ensure the appropriate CRIO leadership is engaged at the right moments. Represent CRIO in sponsor‑facing discussions requiring high‑level operational insight, maintaining confidence through clear and professional communication at all stages. Serve as the operational lead across all active and planned studies within assigned sponsor organizations. Standardize workflows, templates, documentation, and communications across a sponsor’s study portfolio. Provide cross‑study visibility and continuity to ensure long‑term success of enterprise accounts. Lead, guide and support Lead Enterprise Study Managers (LESMs) and Enterprise Study Designers (ESDs) with operational guidance and prioritization alignment across competing timelines. Proactively manage timelines and deliverables, ensuring on‑time execution across the sponsor portfolio. Study Design & Operational Architecture Lead the operational design of Central eSource studies in collaboration with CRIO’s study design team, ensuring configurations align with sponsor protocols, regulatory requirements, and site workflows. Define and document operational workflows, data capture logic, integration touchpoints, and role‑based access structures for each sponsor project. Lead coordination of CDASH mapping, translation workflows, XML file reviews, and country review processes. Review and validate study builds for quality and alignment with agreed sponsor specifications before deployment. Develop standardized frameworks, templates, and study‑level SOPs that accelerate design consistency across sponsor engagements. Drive consistency in amendment processes, UAT strategy, and configuration documentation across studies. Integration Development Coordination Partner with CRIO’s Strategic Integrations Partnership Manager to scope, sequence, and monitor the development of sponsor‑specific integrations (e.g., EDC, CTMS, eRegulatory, lab systems). Internal Resource Orchestration Manage and coordinate internal CRIO design resources assigned to Central eSource projects, ensuring workloads are appropriately scoped and deadlines are met. In collaboration with CRIO’s Strategic Integrations Partnership Manager, facilitate cross‑functional working sessions bringing together study design, product, engineering, QA, and client success at the right time. Identify resource gaps or capacity constraints and escalate proactively to leadership to avoid project delays. Change Management & Project Governance Own the change management process for all in‑flight Central eSource projects, ensuring scope changes are documented, assessed for impact, communicated to sponsors, and routed to appropriate internal teams. Maintain project tracking artifacts including status dashboards, decision logs, open issue trackers, and milestone timelines. Facilitate regular internal and external project reviews, driving action items to resolution and holding all parties accountable. Identify workflow bottlenecks and introduce process improvements to increase efficiency and reduce risk across the portfolio. Surface patterns across sponsor projects that warrant product enhancements and channel feedback into CRIO’s product roadmap process. Communication & Stakeholder Alignment Deliver clear, timely updates to internal and external stakeholders throughout the study lifecycle. Craft high‑quality documentation, change logs, and one‑pager reference materials for both sponsors and internal teams. Support escalation management with professionalism and precision, offering context and resolutions that foster client trust. Act as a communication bridge across LESMs, ESDs, and sponsor contacts to align expectations and deliverables. Partner with leadership to identify and resolve systemic gaps in service delivery or handoff points. Develop onboarding materials and process documentation to support ESD and LESM development. Facilitate internal training sessions on enterprise workflows, tools, and operational expectations. Assist sponsor study teams with understanding eSource functionality, UAT processes, and configuration standards. Promote a culture of continuous learning by mentoring peers and modeling operational best practices. Qualifications Required 7+ years of experience in clinical research technology, eSource, EDC, CTMS, or related clinical trial platforms. Proven track record managing complex, multi‑stakeholder programs involving both sponsor/pharma organizations and internal technology teams. Strong understanding of clinical trial operations, site workflows, and GCP/regulatory requirements relevant to electronic data capture. Familiarity with CDASH standards, study build documentation, and enterprise‑level clinical research operations. Exceptional communication and facilitation skills, with the ability to lead productive discussions with both technical and non‑technical audiences. Demonstrated ability to manage change in dynamic environments, including scoping change requests and managing downstream impact. Preferred Direct experience with CRIO’s eSource platform or comparable Central eSource solutions. Familiarity with HL7 FHIR, API‑based integrations, or clinical data standards (CDASH, CDISC). Experience working in a CRO, sponsor organization, or clinical technology vendor environment. EDC setup and configuration experience Bachelor’s degree in a relevant field (e.g., Clinical Research, Life Sciences, Health Administration). CRIO is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are made based on qualifications, merit, and business need without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, age, or any other basis protected by federal, state, or local law. Disability Accommodation Statement: We are committed to providing reasonable accommodations to individuals with disabilities in the application and interview process. If you require accommodation to participate in the application process, please contact Human Resources to request assistance. Travel Requirements: Occasional travel may be required based on client timelines and sponsor engagement needs. #J-18808-Ljbffr