Remote Senior Associate Director, Site Monitoring

Takeda Pharmaceutical Co.; Massachusetts; Híbrido; USD 154.000 - 243.000; Tempo integral

Resumo da vaga

Takeda Pharmaceutical Co. in Massachusetts (Virtual) seeks a senior leader to oversee site monitoring across assigned clinical studies, driving RBM/RBQM strategies and ensuring ICH-GCP compliance, quality, and on-time delivery within budget.

You will manage CRO partners and internal teams, develop talent, and lead continuous improvement of monitoring processes in a global, fast-paced biotech environment.

Qualificações

• Bachelor’s degree in Life Sciences or international equivalent.
• 8+ years of CRA / site monitoring or site monitoring management experience.
• Global/international team collaboration experience.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Experience with risk-based monitoring models and clinical systems (CTMS, EDC, eTMF, eCOA).

Responsabilidades

• Provide leadership and oversight of site monitoring activities.
• Oversee CRO-delivered site monitoring quality and performance.
• Lead Site Monitoring teams and staff development.
• Ensure inspection readiness and compliant TMF, CTMS, and EDC usage.
• Collaborate with cross-functional study teams and stakeholders.
• Drive RBQM principles and continuous improvement.

Conhecimentos

Leadership

Regulatory knowledge

RBM

Global collaboration

Problem solving

Formação

Bachelor’s degree in Life Sciences

Ferramentas

CTMS

EDC

eTMF

eCOA

Descrição da vaga

Takeda Pharmaceutical Co. in Massachusetts (Virtual) seeks a senior leader to oversee site monitoring across assigned clinical studies, driving RBM/RBQM strategies and ensuring ICH-GCP compliance, quality, and on-time delivery within budget.

You will manage CRO partners and internal teams, develop talent, and lead continuous improvement of monitoring processes in a global, fast-paced biotech environment.