Director, Site Monitoring & RBM Strategy

Takeda Pharmaceutical Co.; Boston (MA); Remote; USD 154.000 - 243.000; Vollzeit

Zusammenfassung

Takeda Pharmaceutical Co. in the United States is seeking a senior Site Monitoring Lead to oversee monitoring activities across studies and regions, ensuring quality, timelines, and budget adherence.

You will drive RBM/RBQM practices and ensure compliance with ICH-GCP and Takeda SOPs, leading a high-performing team or managing CRO partners. This role demands extensive global collaboration, robust leadership, and a track record of building and developing site monitoring teams, with deep knowledge

Qualifikationen

• Bachelor’s Degree in Life Sciences or international equivalent required.
• 8+ years of CRA/site monitoring or management experience in biotech/pharma/CRO.
• Global/international team experience preferred, with cross-location collaboration.

Aufgaben

• Oversee site monitoring planning/execution including visits and oversight visits.
• Provide oversight of CRO site monitoring activities for quality and compliance.
• Lead functional site monitoring leadership within assigned programs.

Kenntnisse

Site monitoring leadership

RBM/RBQM knowledge

ICH/GCP knowledge

Cross-functional collaboration

Ausbildung

Bachelor’s Degree in Life Sciences

Advanced degree desirable

Tools

CTMS

EDC

eTMF

eCOA

Jobbeschreibung

Takeda Pharmaceutical Co. in the United States is seeking a senior Site Monitoring Lead to oversee monitoring activities across studies and regions, ensuring quality, timelines, and budget adherence.

You will drive RBM/RBQM practices and ensure compliance with ICH-GCP and Takeda SOPs, leading a high-performing team or managing CRO partners. This role demands extensive global collaboration, robust leadership, and a track record of building and developing site monitoring teams, with deep knowledge