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The Prostate Cancer Clinical Trials Consortium (PCCTC) is hiring for a Regulatory & Quality Manager. Reporting to the Director of Clinical Operations, the Regulatory & Quality Manager directs and actively manages the development and daily operations of the PCCTC’s clinical research regulatory, monitoring, and quality assurance programs across a portfolio of complex, multi-center clinical trials.
More information about the PCCTC: The Prostate Cancer Clinical Trials Consortium (PCCTC) was initiated in 2005 by the Prostate Cancer Foundation (PCF) and the U.S. Department of Defense (DOD) Prostate Cancer Research Program (PCRP) in response to critically unmet needs in prostate cancer clinical research identified by physician investigators and patient advocates. Established as an independent entity in 2014, the PCCTC, LLC is now the nation’s premier multicenter Clinical Research Organization (CRO) specializing in cutting-edge prostate cancer research. The PCCTC works together with distinguished investigators on a single mission: to design, implement and complete hypothesis-driven early phase trials in prostate cancer, translating scientific discoveries to improved standards of care. To fulfill its mission, the PCCTC developed a unique infrastructure, which has fostered a culture of transparent project co-development between investigators, research sites and industry partners.
Collaborate with the Clinical Operations Manager, Director of Data Management, Coordinators and Monitors in both Clinical Operations (CO) and Clinical Data Management (CDM) to ensure execution of studies in compliance with quality standards (including ICH GCP, local regulations and company Standard Operating Procedures (SOPs)), on schedule and on budget.
Ensure CO regulatory oversight, programs, and staff are adequate to achieve multiple program objectives.
Act as primary liaison between PCCTC and applicable government regulatory agencies.
Develop, enhance and manage PCCTC monitoring program, overseeing and managing monitoring activities and anticipating/adapting to change in regulations and monitoring best practice.
Manage and control PCCTC CO regulatory SOPs; work with all company stakeholders on regulatory SOP content, change control, review and regulatory compliance.
Ensure top quality research is being performed by tracking key metrics, evaluating risks, creating trend reports and implementing policies and procedures for improvement of the entire PCCTC clinical research portfolio of clinical trials including industrial, investigator initiated and externally peer reviewed trials.
A Bachelor’s degree is required with at least 7 years of relevant (clinical research) experience.
At least 4 years of leadership experience.
Comprehensive knowledge of GCP, GMP, FDA oversight and management, Quality Systems, & Pharmacovigilance.
Knowledge of federal, state and institutional regulatory requirements and expectations.
Federal Regulations: Must have a comprehensive knowledge and understanding of the regulations pertaining to human subject protection (including 21 CFR and 45 CFR 46 of the United States Code of Federal Regulations) and Health Insurance Portability and Accountability Act (HIPAA).
Ability to transfer regulation/law into actionable items.
Communication Skills: The ability to independently develop education materials for staff, department, clinicians, review manuscripts, evaluations, and reports and oral communication skills to present complex information in a clear and concise manner.
Information Management Skills: The ability to communicate, explain, interpret, share and present information to employees, management and clinical staff associated with company research projects as well as appropriate external contacts.
Analytical Skills: The ability to perform basic math calculations and as well as a knowledge of statistics and budgeting, budget development and management.
Administrative Skills: The ability to plan and organize meetings, to develop programs, to manage research projects and to prioritize work across several services/departments is essential.
Computer Skills: Microsoft applications at a senior level.
*We offer flexible work arrangement/work from home for up to 3 days/week.
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, a...nd superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.