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The Prostate Cancer Clinical Trials Consortium (PCCTC) is hiring for a Clinical Research Correlative Science Program Manager.
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.
You will be responsible for the management and oversight of the Prostate Cancer Clinical Trials Consortium’s Correlative Science Program including its central unit for the collection, processing and shipment of biospecimens for correlative science research.
Reporting to the Clinical Operations Director, the Clinical Research Correlative Science Program Manager ensures that the Correlative Science Program is efficient and effective in providing best-in-class support for PCCTC's translational research.
Ensure timely execution of assay development for patient selection, stratification, pharmacodynamics, correlative studies and development for clinical trials by working with internal stakeholders and external partners (clinical research organizations, Academic Labs, clinical labs and diagnostic partners) for assigned program(s).
Contribute input to the clinical team for assay development, molecular pathology, and other research-related activities and plans based on regulatory and commercial/consumer requirements/needs. Drive and steer the implementation of the Program's strategic plan in close collaboration with physicians and scientists within the accepted timelines, budgets and resources at the required quality level.
Manages the performance, development, and evaluation of the Correlative Science Program’s team. Utilizes metrics to manage operations and staff performance.
In collaboration with PCCTC Leadership, plans, coordinates and provides estimates (e.g. budget, staffing resources, etc.) for the Correlative Sciences Program.
Work with Clinical Operations Director, to evaluate processes and implement new workflows/procedures. Participates in the planning, development and implementation of the process.
Identify areas requiring a needs assessment analysis. Make recommendations and suggests areas for corrective action or quality improvement based on analytical outcomes.
A Bachelor’s degree is required with at least 7 years of relevant (clinical research) experience.
At least 4 years of management/leadership experience.
Master’s degree or PhD preferred.
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).
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.