Dignity Health ยท 20 hours ago
Research Compliance Project Manager
Phoenix, AZ
Full-time
Onsite
Mid Level
$32.38/hr - $48.17/hr
3+ years expDignity Health is home to the Ivy Brain Tumor Center, a non-profit program focused on clinical trials for aggressive brain cancer. The Ivy Compliance Project Manager will oversee compliance operations, implement quality and privacy frameworks, and ensure adherence to regulatory requirements in clinical research.
Health CareHospitalMedicalNon Profit
Responsibilities
Drive implementation of quality management strategy within Clinical Development, with focus on QMS for a Global Phase 3 Registration Study and Early Phase Clinical Trials
Develop and maintain a Center of Expertise (CoE) around quality management activities (e.g., deviation, continuous improvement, change control) to ensure ongoing alignment of quality-related goals and strategy
Ensure oversight of quality management system by the leadership team including QPPV and Process Excellence & Quality Director
Serve as the primary point of contact for global privacy and data protection matters in clinical research
Interpret, apply, and monitor compliance with global privacy laws and frameworks (e.g., GDPR, UK GDPR, Swiss FADP, HIPAA, CCPA, APAC privacy laws)
Oversee implementation of data protection measures, pseudonymization/anonymization standards, and secure data transfer processes across vendors and collaborators
Lead Data Protection Impact Assessments (DPIAs) and risk assessments related to clinical trial data
Collaborate with Legal/Compliance and external consultants to maintain adherence to global privacy regulations
Support regulatory submissions and inspection readiness by ensuring privacy and quality compliance
Establish and maintain robust quality systems, including document control, deviations, CAPA, change control, and risk management
Oversee the development and implementation of Standard Operating Procedures (SOPs) to ensure consistent adherence to quality and privacy practices
Define key quality and privacy compliance metrics and regularly report on the performance of the systems
Provide timely updates to senior management on quality and privacy trends, issues, and improvement initiatives
Develop and implement training programs for staff on GCP, quality management, and global privacy/data protection requirements
Cultivate a culture of quality, compliance, and data stewardship through ongoing education and effective communication
Qualification
Required
Bachelor's degree and/or Master's degree in healthcare-related or business field
Minimum 3 years related experience
Prior experience working in the research setting and clinical trial billing
Proficient-to-advanced computer skills; proactive, strong organizational skills
Excellent verbal and written interpersonal skills
Extensive experience in quality assurance within the pharmaceutical, biotechnology, or clinical research industry
Proven track record of successfully leading quality initiatives and managing regulatory inspections
Demonstrated experience with privacy regulations in a clinical research context (e.g., GDPR, HIPAA, CCPA)
Strong leadership and interpersonal skills, with the ability to influence and collaborate across functions
Demonstrated ability to drive a culture of continuous improvement and operational excellence
Understanding of Root Cause Analysis and establishing effective corrective and preventative actions
Ability to recognize key issues/gaps, quickly develop insight into underlying issues and propose practical strategies
Effective communication skills, including the ability to convey complex regulatory and privacy requirements to diverse stakeholders
Ability to work effectively/collaboratively cross culturally and cross functionally
Preferred
Supervisory experience or experience in training others, particularly in research
Professional certification in research; CCRP, CCRC, or similar
Privacy/data protection certification preferred (e.g., CIPP/E, CIPM, CISA, or equivalent)
Prior experience working in global clinical research settings with exposure to GDPR compliance, vendor oversight, and cross-border data transfers
Company
Dignity Health
Dignity Health is a healthcare facility that offers physical, mental, and spiritual care.
10001+ employees
H1B Sponsorship
Dignity Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (44)
2024 (55)
2023 (38)
2022 (37)
2021 (33)
2020 (20)
Funding
Current Stage
Late StageTotal Funding
unknown2019-02-01Acquired
Leadership Team
Gena Bravo
President/CEO
Linda Tautz RN, BSN, MBA
Regional Chief Executive Officer
Recent News
2025-10-01
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