Research Compliance Project Manager

Hello humankindness Located conveniently in the heart of Phoenix ArizonaSt. Josephs Hospital and Medical Center is a 571-bed not-for-profit hospital that provides a wide range of health social and support services. Founded in 1895 by the Sisters of Mercy St. Josephs was the first hospital in the Phoenix area. More than 125 years later St. Josephs remains dedicated to its mission of caring for the poor and underserved. We are extremely proud to be a nationally recognized center for quality quaternary care medical education and research. St. Josephs includes the internationally renowned Barrow Neurological Institute Norton Thoracic Institute Cancer Center at St. Josephs Ivy Brain Tumor Center and St. Josephs Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics neuro-rehabilitation orthopedics and other medical services. St. Josephs is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day approximately 20 percent of the hospitals patients have traveled from outside of Arizona and the United States to seek treatment at St. Josephs. U.S News & World Report routinely ranks St. Josephs among the top hospitals in the United States for neurology and addition St. Josephs boasts the Creighton University School of Medicine at St. Josephs and a strategic alliance with Phoenix Childrens Hospital. St. Josephs is consistently named an outstanding place to work and one of Arizonas healthiest employers. Come grow your career with one of Arizonas Most Admired Companies. Look for us on Facebookand follow us on Twitter. For the health of our community ... we are proud to be a tobacco-free campus.

The Ivy Brain Tumor Center is a non-conventional non-profit program offering state-of-the-art clinical trials for patients with the most aggressive form of brain cancer. It is home to the largest collection of Phase 0 trials for brain tumors in the world. Our multidisciplinary team of brain tumor specialists and scientists are accelerating drug discovery and precision medicine in neuro-oncology to identify the most promising first-in-class therapies for brain tumor patients.

The Ivy Compliance Project Manager is responsible and accountable for supervising Ivy Center compliance operations across quality management and privacy. This role will drive the implementation of quality and privacy frameworks in alignment with international regulatory requirements including FDA ICH GCP GDPR HIPAA and other applicable data protection laws.

Role 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.

Basic Qualifications:
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.

Required Qualifications:

Bachelors degree and/or Masters 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.

Preferred Qualifications:
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.