Study Start-Up Specialist

Stelle nicht auf LinkedIn

🕒 vor 10 Tagen

🇺🇸 Vereinigte Staaten – Remote

⏰ Vollzeit

🟡 Mittelstufe

🟠 Senior

👻 Geisterscore 12%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Lebenslauf hochladen

ECN

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

Gegründet 1955

⚡ Energie

🔬 Wissenschaft

Energy • Science

ECN ist das Energieforschungszentrum der Niederlande und eine der größten Forschungseinrichtungen Europas. Im Mittelpunkt steht die Gestaltung des Übergangs zu einem nachhaltigen Energiesystem. ECN entwickelt Wissen und Technologien in den Bereichen nachhaltige Energieerzeugung, Energieeffizienz, Systemintegration und Umweltauswirkungen. Darüber hinaus führt die Organisation Messungen, Materialprüfungen, Analysen, politische Studien und Technologieentwicklungen durch. Zu den ausgewiesenen Schwerpunkten von ECN gehören Solar- und Windenergie, Biomasse, Energieeffizienz, Energietechnik, Umwelt, energiepolitische Studien und Systemintegration – mit dem Ziel, sichere, effiziente, zuverlässige und umweltfreundliche Energiesysteme zu schaffen.

Beschreibung

• Initiate end-to-end study start-up activities upon receipt of study award notification at pre-award, including supporting the PAE Director on recruitment strategy • Own and maintain the PAE study start-up task management system from Pre-Award through Greenlight Activation • Track workflow stages, assigned owners, due dates, escalation triggers, and process milestones • Monitor CTA execution, SIV/Greenlight dates, IRB approvals, sponsor approvals, and essential document collection • Proactively escalate delays to the PAE Director • Coordinate with Contracts & Budgets on study awards, contract execution timelines, and CTA signing status • Serve as the PAE liaison to ensure recruitment preparation is not delayed by contract finalization • Mentor junior PAE start-up and recruitment coordinators • Identify study start-up bottlenecks and lead process improvement initiatives, including SOP, workflow template, and task management system updates • Partner with the PAE Director on department-wide start-up strategy • Represent PAE study start-up operations in cross-departmental leadership discussions and provide senior stakeholder updates • Track, collect, and manage essential study start-up documents, including protocols, ICFs, sponsor-required materials, and site-specific documentation • Ensure IRB and sponsor approvals are obtained before deploying patient-facing recruitment materials • Coordinate with Regulatory on IRB submission and approval timelines and ensure recruitment materials use IRB-approved language • Submit recruitment budget requests to Finance and track approved spend • Submit budget amendment requests as needed • Support vendor payment processes and maintain Google and Meta advertising vendors on an invoicing model • Conduct mandatory 30-day recruitment performance reviews for active studies • Synthesize portfolio-wide recruitment start-up performance trends and present recommendations to the PAE Director • Coordinate with Business Development, Operations, Regulatory, Contracts & Budgets, Finance, and Site Management • Communicate confirmed Greenlight and SIV dates to the PAE team to coordinate patient matching, outreach scheduling, and mass text deployment

🎯 Anforderungen

• Bachelor's degree in Healthcare Administration, Life Sciences, Business, Communications, Marketing, or a related field • Equivalent combination of education and directly relevant experience will be considered • Minimum 3–5 years of experience in clinical research, patient recruitment, study start-up, or a related healthcare/CRO environment • Experience managing end-to-end clinical trial start-up workflows • Cross-functional coordination across regulatory, contracts, finance, and operations teams • Ability to lead process improvement initiatives and contribute to strategic planning • Experience tracking and managing essential study documents and regulatory approval processes, including IRB and sponsor approvals • Experience working with or alongside Contracts & Budgets teams on clinical trial agreement execution and study award processes • Proficiency in RealTime CTMS or comparable clinical trial management system • Proficiency in Microsoft Office Suite: Word, Excel, PowerPoint, and Outlook • Experience with Microsoft Planner, Teams, or equivalent project management tools • Experience with IRB submission portals and regulatory tracking tools/processes • Ability to manage multiple concurrent studies with competing deadlines in a fast-paced environment • Strong attention to detail and commitment to document accuracy and process compliance • Ability to work cross-functionally with multiple departments and external vendors • Availability to respond promptly when study award notifications are received, including at the start of compressed CTA/SIV timelines • Working knowledge of ICH-GCP guidelines, FDA regulations, and IRB processes • Experience building or managing recruitment performance dashboards or business intelligence reporting tools • Prior experience mentoring, training, or providing informal leadership to team members • Must have a dedicated, distraction-free remote work environment with reliable high-speed internet access • Must be available during core business hours and responsive during study award notification periods regardless of time zone

🏖️ Vorteile

• Dedicated, distraction-free remote work environment requirement • Reliable high-speed internet access requirement • Remote work arrangement • Availability during core business hours with responsiveness during study award notification periods regardless of time zone • Defined growth path to Associate Director, Patient Advocacy & Engagement