Research Compliance Project Manager

** Job Summary and Responsibilities*
* 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.

** Job Requirements*
* 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:

- 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…