Senior CRA Functional Manager

🕒 Outubro 28

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $136.400 - $181.400 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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• Aberta há 14 dias.
• As vagas desta empresa costumam ser preenchidas em 42 dias.

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BeOne Medicines

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 2010

🧬 Biotecnologia

🏥 Saúde

💊 Farmacêutico

Biotechnology • Healthcare • Pharmaceuticals

A BeOne Medicines é uma empresa global de oncologia, com sede na Suíça, que descobre e desenvolve tratamentos inovadores mais acessíveis e com maior disponibilidade para pacientes com câncer em todo o mundo. Com um portfólio que abrange hematologia e tumores sólidos, a BeOne está acelerando o desenvolvimento de seu diversificado pipeline de novas terapias por meio de capacidades internas e colaborações. Com uma equipe global em crescimento, formada por mais de 11.000 colaboradores presentes em seis continentes, a empresa está comprometida em melhorar radicalmente o acesso a medicamentos para muito mais pacientes que deles precisam.

Descrição

• Develop resourcing strategies and provide personnel oversight within the Site Management organization • Develop metrics and KPIs for CRA staff and monitor continuous improvement using technology and analytic platforms • Lead CRA Managers and their staff, ensuring accountability for study assignments, training, and metrics review • Provide performance management, coaching, and mentoring for assigned management staff • Ensure monitoring expectations comply with monitoring SOPs, GCP guidelines, country-specific regulations, and quality and risk-based effectiveness standards • Conduct assessments, co-monitoring visits, Investigator meetings, or Booster visits as needed to evaluate CRA staff • Drive improvements to optimize effectiveness and efficiency within Site Management and the greater Americas region • Oversee monitoring quality and related metrics, including trip-report turnaround, trip-report quality, action-item management, query management, data currency, and TMF management • Manage relationships with CRO FSP line managers and respond to feedback regarding direct reports, studies, and programs • Act as escalation point for CTOMs and study teams regarding CRA-related issues and concerns • Ensure adequate monitoring allocations and relevant training for direct reports’ projects • Support BeiGene RBx strategy and engagement of direct reports • Document monitoring oversight activities according to ICH-GCP and BeOne standards • Assist with investigator and site identification • Manage site trends through dashboard review and ongoing risk assessment • Collaborate with clinical study teams and sites to deliver study milestones, including startup, recruitment, database analyses, and closeout • Establish communication with stakeholders to manage clinical delivery and report or escalate issues • Review monitoring reports for quality oversight • Support site audits and inspections and follow through on findings to resolution

🎯 Requisitos

• BS/BA in a relevant scientific discipline • Minimum of 8-9 years of relevant Clinical Operations experience • 4-5 years combining personnel and trial management experience • Minimum of 4-5 years of monitoring experience • Experience in oncology global trials preferred • Knowledge of monitoring SOPs, GCP guidelines, country-specific regulations, and quality and risk-based monitoring • Ability to develop metrics and KPIs • Ability to conduct performance management, coaching, and mentoring • Ability to manage CRO FSP line-manager relationships • Ability to work with CTOMs, Clinical Study Teams, investigators, and internal and external stakeholders • Ability to support site audits and inspections and resolve findings • Ability to follow ICH-GCP and BeOne standards

🏖️ Benefícios

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness

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