Associate Director, Registry Operations Management

🕒 Outubro 19

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟠 Sênior

⚙️ Operações

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• Provide operational leadership for assigned registries across start-up, site activation, enrollment, ongoing data collection, maintenance, and closeout • Convert protocols, contracts, client commitments, and program objectives into integrated plans, milestones, staffing assumptions, and risk controls • Monitor portfolio health and intervene on material risks, dependencies, delays, quality issues, and scope changes • Ensure program records, governance, and operational decisions are documented according to company procedures and applicable requirements • Coordinate delivery with Clinical Operations, Data Management, Biostatistics, Epidemiology, Medical and Scientific Affairs, Quality, Technology, Finance, Contracts, and client-facing teams • Clarify accountability, handoffs, decision rights, and dependencies across functions • Lead operational reviews and governance discussions for assigned programs • Communicate status updates, options, and recommendations to senior internal stakeholders and clients • Oversee site activation, enrollment, retention, data collection, and participation trends • Guide targeted plans for underperforming sites • Use key operational indicators to identify emerging issues and improve site engagement and registry performance • Represent Registry Operations in client meetings and planning forums • Assess operational, timeline, resource, and financial impacts of proposed changes • Promote quality, compliance, inspection readiness, patient-centered research, and timely issue escalation • Partner on audits, inspections, investigations, corrective and preventive actions, and remediation • Lead process improvements to strengthen consistency, cycle time, stakeholder experience, and operational scalability • Develop practical standards, tools, and metrics • Coach and develop Registry Operations colleagues; set expectations, manage workloads, and support talent development and succession planning • Contribute operational expertise to feasibility assessments, proposals, budgets, resource estimates, and portfolio capacity planning • Contribute to annual planning and strategic initiatives involving registry growth, technology adoption, and the operating model

🎯 Requisitos

• Bachelor’s degree in life sciences, healthcare, public health, clinical research, business, or a related field is required • An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient • Typically, 8 or more years of experience in clinical research operations, registry operations, observational research, real-world evidence, clinical operations, or a related area is required • Demonstrated success leading complex cross-functional programs and working with sites or site networks in a regulated research environment is required • Experience with people-management or significant team leadership equivalent to 5 years is required • Experience with longitudinal registries, observational studies, or post-marketing research and with biopharmaceutical or biotechnology clients is preferred • Must be able to work East Coast hours • Must be legally authorized to work in the US without sponsorship • Must be able to pass a comprehensive background check, including a drug screening • Strong program leadership, planning, risk management, issue resolution, and performance management skills • Ability to interpret operational data and turn findings into clear actions and recommendations • Sound judgment in balancing scientific, operational, client, financial, and organizational needs • Effective written and verbal communication, stakeholder management, negotiation, and influencing skills • Ability to lead through ambiguity, solve root causes, and implement improvements that last

🏖️ Benefícios

• Fully remote work arrangement • Relocation assistance is NOT provided • Reasonable accommodation for individuals with disabilities • Equal employment opportunity and affirmative action protections

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