Research Data Compliance Manager - Scientific Computing & Data

Strength Through Diversity

Ground breaking science. Advancing medicine. Healing made personal.

Roles & Responsibilities: 

Mount Sinai is among New York City's largest employers, with 42,000+ team members in both clinical and non-clinical roles throughout our eight hospital campuses and world-renowned medical school. We are one of the metro area's largest health care providers, with hundreds of ambulatory, primary, and specialty care facilities across the five boroughs, northeastern region and beyond.

Mount Sinai Health System recognizes data is one of our most strategic assets and should be governed appropriately to protect the privacy of our millions of patients while safely sharing the data with the employees/researchers/third parties who have permission to use it in alignment with our multi-part mission of patient care, education and research.

The mission of Scientific Computing and Data (SCD) group at the Icahn School of Medicine at Mount Sinai is to accelerate biomedical discovery and translation through collaborative research using high-performance computing, biomedical informatics and data science. We enable nearly $200 million/year in NIH-funded biomedical research. 

The Compliance Manager is an individual contributor reporting to the Dean for Scientific Computing and Data. In this role, you’ll ensure that the Scientific Computing and Data team follows all local, state, federal regulations, as well as Mount Sinai’s policies, legal, ethical, intellectual property and cybersecurity guidelines for use of protected health information for research and clinical purposes. You will collaborate closely with several stakeholder groups internal and external to the Scientific Computing and Data team to facilitate the development, implementation and audit of processes, usage agreements, policies, and procedures for SCD to enable basic and translational scientists. Priorities will be ensuring that multi-modal data access, usage, and sharing both internal and external to Mount Sinai and AI-enabled applications and computation is consistent with all regulatory guidelines.

The Compliance Manager will be responsible for all facets of policy and process development for data access, usage and sharing. These responsibilities include collaborating with Mount Sinai’s departments for compliance, privacy, legal, research, IRB, digital and technology partners (IT) and others as necessary to ensure policies are aligned with federal and state laws, Mount Sinai corporate policies, and industry privacy standards.  As policies are updated, this role will implement the accompanying processes and procedures, working with key enablement areas such as data delivery and service teams, computational and AI user support, cybersecurity and others as needed.

• Identify the need for and lead the development or revision of policies and procedures pertaining to data access, usage, and sharing to ensure regulatory compliance and adherence to industry best practices. 
• Ensure all regulatory and compliance processes are documented.
• Identify the need for process improvements or policy schange based on regulatory changes.
• Maintain knowledge of local, state, and federal regulations related to patient privacy and data sharing compliance (e.g. HIPAA, reuse of genetic testing results, Title 42 CFR Part 2, New York’s Article 27-F, 21CFR Part 11, etc.). Escalate risks and adapt processes based on regulatory changes. Serve as a compliance subject-matter expert to Mount Sinai’s leaders and other stakeholders.
• Ensure that data access and usage policies and procedures adhere to Mount Sinai’s policies pertaining to special patient categories (e.g., employees, volunteers, providers, board members, celebrities).
• Design and implement programs to foster awareness and adherence to compliance policies and processes.
• Work with key stakeholders to develop data use agreements (DUAs) and accompanying compliance processes for different types of end users (e.g., clinicians, researchers, administrators, hybrid, external vendors, collaborative research projects). 
• Develop and provide communication, training, and job aids/tip sheets to explain data access and usage procedures, policies, and requirements for Data Use Agreements and other data-related processes to end users.
• Collaborate effectively with Mount Sinai Research Compliance, IRB, Legal, intellectual property (Mount Sinai Innovation Partners), cybersecurity (Digital and Technology Partners) and the Institutional Review Board (IRB) on policies and procedures.
• Develop auditing procedures, checklists, agreements, audit criteria and metrics to track compliance. Work with Mount Sinai research compliance to support their reviews.
• Facilitate the escalation, investigation, and resolution of compliance issues.
• Work with information security and application owners to implement approved enterprise data access policies and ongoing (re)attestation processes for a variety of sensitive data sets, including Centers for Medicare and Medicaid Services (CMS) data.
• Perform due diligence on universal research consent practices used at other institutions and present recommendations/options to key stakeholders for approval. Work with consent tracking application owners (currently Epic and REDCap) to implement approved consenting.
• Lead efforts to implement compliance with Title 21 CFR Part 11 for clinical trial infrastructure, where needed, in patient registries such as REDCap.
• Lead efforts to implement compliance processes to share return of genomic results (somatic and germline).
• Guide SCD’s Institutional Review Board (IRB) applications for data sharing sources, such as the Mount Sinai Data Warehouse and Data Ark data commons.
• Participate in various Mount Sinai-wide research, compliance, and technology governance committees.
• Provide guidance and assist with grant proposals including NIH data sharing p[ans.
• Other duties as assigned.

• Bachelor degree in a technical discipline; PhD or legal degree preferred.
• Expert knowledge of compliance and regulatory requirements in the healthcare and biomedical research environment (HIPAA, IRB, GDPR, etc).
• Ten+ years of experience in developing and/or supporting technology/data management efforts at an academic medical center.
• Demonstrated experience completing projects.
• Demonstrated experience creating policies and processes.
• Excellent communicator for general, healthcare, and technical matters with strong writing and presentation skills.
• Experience discussing new and complex topics in a simple, easy-to-understand way.
• Excellent leadership and partnership skills.

Strength Through Diversity

The Mount Sinai Health System believes that diversity, equity, and inclusion are key drivers for excellence. We share a common devotion to delivering exceptional patient care. When you join us, you become a part of Mount Sinai’s unrivaled record of achievement, education, and advancement as we revolutionize medicine together. We invite you to participate actively as a part of the Mount Sinai Health System team by:  

• Using a lens of equity in all aspects of patient care delivery, education, and research to promote policies and practices to allow opportunities for all to thrive and reach their potential.
• Serving as a role model confronting racist, sexist, or other inappropriate actions by speaking up, challenging exclusionary organizational practices, and standing side-by-side in support of colleagues who experience discrimination.
• Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers.

At Mount Sinai, our leaders strive to learn, empower others, and embrace change to further advance equity and improve the well-being of staff, patients, and the organization.  We expect our leaders to embrace anti-racism, create a collaborative and respectful environment, and constructively disrupt the status quo to improve the system and enhance care for our patients. We work hard to create an inclusive, welcoming and nurturing work environment where all feel they are valued, belong and are able to advance professionally.

 Explore more about this opportunity and how you can help us write a new chapter in our history!

“About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,400 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 14 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression. We are passionately committed to addressing racism and its effects on our faculty, staff, students, trainees, patients, visitors, and the communities we serve. Our goal is for Mount Sinai to become an anti-racist health care and learning institution that intentionally addresses structural racism.”

EOE Minorities/Women/Disabled/Veterans