
Enterprise Solutions Lead – Study Operations
CRIO
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $90,000 - $130,000 per year
Job Level
Tech Stack
About the role
- 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.
- 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.
- Define and document operational workflows, data capture logic, integration touchpoints, and role-based access structures for each sponsor project.
Requirements
- 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.
- Bachelor's degree in a relevant field (e.g., Clinical Research, Life Sciences, Health Administration).
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical research technologyeSourceEDCCTMSclinical trial operationsdata capture logicintegration touchpointsrole-based access structuresCDASH standardsstudy build documentation
Soft Skills
communication skillsfacilitation skillsleadershipproblem-solvingchange managementstakeholder managementorganizational skillstimelines managementprofessional communicationcollaboration
Certifications
Bachelor's degree in Clinical ResearchBachelor's degree in Life SciencesBachelor's degree in Health Administration