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The Prostate Cancer Clinical Trials Consortium (PCCTC) is hiring a Contract 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.
Reporting to the CEO-PCCTC, as a Contract Manager ,
Direct and actively manage the development and daily operations of PCCTC's contracts administration program including reviews, negotiates and manages the process of executing Clinical Trial Agreements (CTA) with industry partners and other academic medical centers; and communicates with internal and external business and legal counterparts.
Act as contracts liaise with protocol development, budget and compliance functions at PCCTC, among others, and, when appropriate, with external sponsors.
Ensure top-quality contracts negotiation 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. This entails negotiation and execution of all agreements associated with industrial sponsored clinical trials such as, master clinical trial agreements, clinical trial agreements, confidentiality disclosure agreements, service agreements and sub-contract services.
Work directly with the research management staff as well as general counsel at all participating institutions, and Industrial Sponsors to ensure full compliance with federal regulations related to the conduct of clinical trials.
Manage all site participation agreements for research sites participating in company research activities.
A Bachelor's degree with at least 7 years of relevant experience (Experience with clinical trials-related agreements or other research agreements including an understanding of industrial trials and industrial sponsor relationships. In lieu of clinical trials experience, comparable experience in contracts/ negotiations would be applicable (e.g., paralegal experience).
A Masters degree/JD is preferred with at least 2 years of relevant experience.
Working knowledge of rules and regulations related to Human Subject Research, Good Clinical Practice, regulatory compliance and intellectual property.
Strong analytic and problem-solving skills; ability to work independently.
Excellent verbal and written communication skills.
Ability to work on multiple projects, to prioritize and to meet deadlines.
Ability to work well with other members of OTD, other departments at MSK, and external parties
* We offer flexible work arrangements.
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.