Direct and drive the implementation of compliance management related to quality events and internal audits for clinical trial delivery functions including the identification and development of applicable processes and tools
Establish and lead proactive risk-based compliance assessments for clinical trial delivery functions and ensure completion of robust CAPA/EC-related compliance assessment
Develop and report to leadership on key performance indicators and mitigation strategies for clinical trial delivery
Oversee and manage quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting
Facilitate clinical trial delivery internal audits with study teams and functional areas including but not limited to: study team preparation, facilitating audit requests, managing audit responses and CAPA development and implementation
Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation.
Lead clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical trial delivery procedures and developing effective mitigation and escalation strategies
Proactively identify process/therapeutic area/project risks and develop/lead assessments to assess compliance
Advise process owners and functional areas on the development and implementation of effective mitigation and escalation strategies for projects to address risks and issues
Develop, lead and oversee compliance assessments to address GCP Quality Plan, CAPAs/ECs and liaise with QA to ensure adherence to the plan
Engage and build relationships with clinical trial delivery functions, R&D QA, and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities
Identify, develop, and track KPIs, metrics and dashboards to track process quality and compliance
Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops innovative thinkers
Act as role model for Takeda’s values

Requirements

Bachelor’s Degree or international equivalent required; Life Sciences preferred
8+ years' experience in the pharmaceutical industry and/or clinical research organization, including 6+ years in compliance or clinical study management
Experience in leading projects and coordinating collaboration with cross-functional teams
Strong strategic thinking, planning, execution, and communication skills
Global/international experience required, including ability to collaborate with colleagues and staff in other locations
Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development
Health care business acumen with a comprehensive understanding of the pharmaceutical industry.

Benefits

medical, dental, vision insurance
401(k) plan and company match
short-term and long-term disability coverage
basic life insurance
tuition reimbursement program
paid volunteer time off
company holidays
well-being benefits
up to 80 hours of sick time
new hires are eligible to accrue up to 120 hours of paid vacation

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

compliance managementCAPA developmentroot cause analysisGCP complianceclinical trial deliveryrisk assessmentperformance metricsdata analyticsquality assuranceclinical study management

Soft Skills

strategic thinkingplanningexecutioncommunicationleadershipmentoringcollaborationrelationship buildingcoachingproblem-solving