Enterprise Solutions Lead – Study Operations

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CRIO

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51 - 200 Mitarbeiter

⚕️ Krankenversicherung

☁️ SaaS

💊 Pharmazie

💰 €9.000.000 Series B im 2022-01

Healthcare Insurance • SaaS • Pharmaceuticals

CRIO ist eine intuitive eSource- und klinische Studien-Softwareplattform, die protokollbasierte Daten direkt am Punkt der Patienteninteraktion erfasst, um die Belastung der Standorte zu verringern und die Datenqualität zu verbessern. Entwickelt von Experten der klinischen Forschung, bietet CRIO konfigurierbare Vorlagen, Echtzeit-Datenzugriff für Remote-Überwachung, integrierte Berichts- und Anfragetools sowie ein verbundenes Ökosystem, das eSource, EDC, eConsent, CTMS und eRegulatory-Module umfasst. Es bedient Sponsoren, CROs und klinische Standorte, um den Studienstart zu beschleunigen, die Rekrutierung zu erhöhen und Protokollabweichungen zu reduzieren.

Beschreibung

• 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.

🎯 Anforderungen

• 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).

🏖️ Vorteile

• Health insurance • 401(k) matching • Paid time off • Flexible work arrangements • Professional development opportunities