Clinical Data Manager, Prostate Cancer Clinical Trials Consortium (PCCTC)
Job Posting Number: 23944
New York, NY
November 18, 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 for a Clinical Data Manager. As an integral member of the research team and in compliance with all regulatory, institutional, and departmental requirements the Clinical Data Manager provides requirements specifications for instrument design (eCRFs/databases, edit checks) for data acquisition for clinical trials performs data cleaning activities to review, analyze and validate data to ensure completeness, integrity and accuracy.
- Design Case Report Forms(CRFs)/database requirements/specifications (includes field definitions, automatic edit checks, indication of critical variables and CRF Completion Guidelines).
- Assist in design of queries using SQL to check for missing or inconsistent eCRF data.
- Understand, update and optimize existing queries/reports.
- Query tracking and resolution (i.e. correspondence with investigator sites to obtain resolution to queries).
- Analyze data to find potential issues/inconsistencies/areas, etc.
- eCRF data validation (i.e. scrubbing , cleaning, query generation, applying data handling conventions).
- Train users on EDC functionality.
- Provide necessary documentation in compliance with existing standard operating procedures, regulatory guidelines, etc.
- Maintain necessary clinical trial conduct documentation (includes Data Management Plans: database specifications, electronic edit checks, External Data Transfer Plan, etc.).
- Communicate and work effectively with Clinical Operations team.
- 2 years or more of clinical data management and clinical research experience or as determined by hiring manager.
- In lieu of a Bachelor’s degree, 4 years of job-related work experience can be accepted.
- Certified Clinical Data Manager Certification (CCDM) Preferred.
- 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).
- Excellent computer skills including proficiency in SQL and MS Office products.
- Experience working in an FDA regulated environment a plus.
- Comfortable working in a fast-paced environment.
- Strong organizational, time and project management skills.
- Excellent interpersonal, verbal and written communication skills.
- Experience and/or desire to learn working with various EDC systems: Medidata Rave, Caisis, InForm, etc.
More information about the PCCTC:
The Prostate Cancer Clinical Trials Consortium (PCCTC) was initiated in 2005 in response to critically unmet needs in prostate cancer clinical research identified by investigators and patient advocates. Now the nation’s premier multicenter clinical research organization specializing in cutting-edge prostate cancer research, the PCCTC’s distinguished investigators work together 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. Using its unique infrastructure to implement transparent project co-development between investigators, research sites and industry partners, the PCCTC has established a new paradigm for evaluating prostate cancer therapies.
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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