Associate Director, Site Monitoring

Regulatory Toolkit; Massachusetts; Hybrid; USD 154,000 - 243,000; Full time

Job summary

Takeda seeks a Site Monitoring Leader to oversee monitoring activities across clinical studies, ensuring quality, timelines, and budget adherence. You will drive RBM/RBQM strategies, ensure compliance with ICH-GCP and Takeda SOPs, and lead CRO/site monitoring performance.

This role requires 8+ years of CRA/site monitoring, global collaboration, and proven leadership of large teams. Massachusetts - Virtual; base salary range is shown.

Qualifications

• Bachelor’s Degree or international equivalent; Life Sciences preferred; advanced degree highly desirable.
• 8+ years of CRA / site monitoring or site monitoring management experience in biotech/pharma/CRO.
• Global/international team experience and collaboration across locations.
• Strong knowledge of ICH/GCP and related regulations; RBM/RBQM experience.
• Experience with CTMS, EDC, eTMF and eCOA systems.
• Proven leadership of large site monitoring teams and delivery of quality results.

Responsibilities

• Oversee planning and execution of site monitoring activities across studies and regions.
• Provide CRO oversight ensuring quality, compliance, and performance.
• Lead and develop site monitoring teams and coordinate with cross-functional study teams.
• Maintain inspection readiness and proper TMF/CTMS/EDC documentation.
• Collaborate with stakeholders to ensure seamless study execution.
• Drive RBQM adoption and continuous improvement in site monitoring practices.

Skills

Leadership

Cross-functional collaboration

Regulatory knowledge

Risk-based monitoring

Education

Bachelor’s Degree or international equivalent

Advanced degree desirable

Tools

CTMS

EDC

eTMF

eCOA

Job description

Job Description

Objective / Purpose:

• Provide leadership and oversight of site monitoring activities across assigned clinical studies or regions to ensure delivery in line with quality, timelines, and budget.
• Drive execution of Takeda’s site monitoring strategy, including Risk-Based Monitoring (RBM/RBQM) approaches and internalized monitoring capabilities.
• Ensure compliance with ICH-GCP, local regulatory requirements, and Takeda SOPs across all site monitoring activities.
• Lead and develop a high-performing team and/or oversee FSP and CRO site monitoring performance to support efficient clinical trial delivery.

Accountabilities

Site Monitoring Oversight & Delivery

• Oversee compliance and quality of the planning and execution of site monitoring activities including Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, Close-Out Visits, and Monitoring Oversight Visits.
• Ensure study-specific site monitoring plans are developed, approved, and executed using Takeda standards and systems.
• Provide oversight of CRO-delivered site monitoring activities, ensuring quality, compliance, and performance expectations are met.
• Assess trends in site monitoring visit conduct, reporting, issues, and corrective actions.

Operational Leadership

• Serve as functional leader for site monitoring within assigned programs, ensuring alignment with study teams and cross‑functional stakeholders.
• Act as escalation point for site‑related and site monitoring issues, ensuring timely resolution and risk mitigation.
• Contribute to study start‑up, execution, and close‑out phases through strategic input and operational oversight of site monitoring.
• Drive consistent execution of RBQM principles and continuous improvement in site monitoring.

People Leadership & Development

• Provide line management and/or functional oversight of Site Monitors and Site Monitoring Leads.
• Ensure appropriate training, onboarding, and ongoing development of team members to maintain high‑quality site monitoring standards.
• Foster a culture of accountability, collaboration, and continuous improvement across the site monitoring organization.
• Support talent development, succession planning, and performance management.

Quality, Compliance & Inspection Readiness

• Ensure adherence to all applicable regulatory requirements, Takeda SOPs, and quality standards.
• Maintain inspection readiness of site monitoring processes and deliverables at all times, supporting audits and regulatory inspections.
• Ensure accurate use of and documentation in TMF, CTMS, and EDC systems.

Stakeholder Collaboration

• Partner with Clinical Study Management, Clinical Study Site Engagement, Data Management, and other cross‑functional teams to ensure seamless study execution.
• Act as subject matter expert for site monitoring in cross‑functional initiatives, stakeholder engagements, and process improvements.
• Provide input into resource planning and budget forecasting for site monitoring activities.

Process Improvement & Innovation

• Lead or contribute to initiatives to optimize monitoring processes, tools, and technologies.
• Promote best practices, lessons learned, and continuous improvement across studies and programs.

Education & Competencies (Technical and Behavioral):

• Bachelor’s Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.
• 8+ years of CRA / clinical site monitoring or site monitoring line/functional management experience within the biotech/pharma/CRO industry.
• Global/international team experience preferred, including ability to collaborate with colleagues and staff in other locations.
• Strong understanding of ICH/GCP and associated regulations
• Experience with risk‑based monitoring models and clinical systems including CTMS, EDC, eTMF, and eCOA.
• Proven track record of leading a site monitoring team and driving quality execution.
• Track record of successful leadership, management, and development of large site monitoring teams.

Takeda Compensation and Benefits Summary

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$154,400.00 - $242,550.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub‑Type

Regular

Time Type

Full time

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.