New · posted Oct 31
Takeda · Pharmaceuticals
Associate Director, Site Monitoring
- Remote, US
- Remote
- Full-time
- Director
The role
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.
What you need
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.
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.
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.
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
Pay
$154,400 – $242,550 a year
Employer providedU.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.
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
Working conditions
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
From the posting
About Takeda
For Location
Massachusetts - Virtual
Job Exempt
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.
Equal opportunity, accessibility and legal noticesTakeda's statements, word for word
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
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.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This roleEmployer provided
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $154,400 | — | $242,550 |
This role: Takeda's own published range.
Career trajectory
Where this role sits in Clinical Research
The general path across 14 open Clinical Research roles on Regulatory Jobs, with the titles they carry most. Not Takeda's own promotion track.
Career resources on Clinical Research
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct24
- Collaboration and leadership12
- GMP and compliance5
- Documentation and SOPs5
- Quality systems and risk4
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Takeda on Regulatory Jobs
- 64
- Open roles
- 61
- Distinct roles
- 16
- Locations
By discipline
- Regulatory24 38%
- Clinical21 33%
- Quality18 28%
By level
- Director37 58%
- Senior & Principal12 19%
- Manager9 14%
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Associate Director, Site Monitoring at Takeda
Open until filled. $154K–$243K a year, employer provided.