Research Project Manager (IRONMAN), Prostate Cancer Clinical Trials Consortium (PCCTC)
Job Posting Number: 22946
New York, NY
June 8, 2018
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes.
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The Prostate Cancer Clinical Trials Consortium (PCCTC) is hiring a Research Project Manager (RPM). As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements, the Research Project Manager is responsible for providing support to the Clinical Operations Program Manager and Chief Executive Officer for multi-center clinical trial activities. Commitment to accuracy, high attention-to-detail, and ability to work independently are critical competencies for the role.
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.
- Manage and champion a highly complex multi-institutional, international, prospectively designed clinical registry in addition to clinical trials as required by the Company.
- Design and oversee operational and quality plans on an international scale, including concept development, correlative and translational design, protocol and informed consent drafting, safety and regulatory document drafting, monitoring and quality plan drafting, etc.
- Communicate effectively by establishing strong working relationships with a diverse matrix of clinical trial sites, investigators, pharmaceutical & biotechnology executives, registry executive committee members, and other important stakeholders.
- Synthesize complex clinical, regulatory, and other clinical trial and registry information into actionable plans.
- Provide necessary documentation in compliance with existing standard operating procedures, regulatory guidelines, etc.
- Assist in maintaining necessary clinical trial and registry conduct documentation (includes Project Management Plans, Safety Management Plans, Monitoring Plans, Meeting Minutes, etc.).
- Communicate and work effectively with all stakeholders of the PCCTC – Executive Leadership, Clinical Operations, Informatics, Business Management, Budgets & Contracts, Editorial, etc.
- 4-7 years of relevant (clinical research) experience, or as determined by hiring manager.
- A Masters degree is preferred.
- Proven ability to manage clinical research projects with strict deadlines.
- Knowledge and experience with clinical trial execution.
- Working knowledge of the Code of Federal Regulations, Good Clinical Practice, and Human Subjects Protection.
- Knowledge of clinical trial regulatory and safety management preferred.
- Comfortable working in a fast-paced environment.
- Strong organizational, prioritization, and project management skills.
- Strong computing skills including proficiency in MS Office products.
- Excellent interpersonal, verbal and written communication skills.
- Ability to solve problems by using a logical, systematic, sequential approach.
- Experience working with prostate cancer clinical trials and/or large scale registry projects is a plus.
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.
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