Prostate Cancer Clinical Trials Consortium (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. Incubated within Memorial Sloan Kettering (MSK) and in 2014 established as an independent entity the PCCTC, LLC it is now the nations 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.

PCCTC is hiring for a Clinical Data Manager . In this role, you will provide 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. Works on complex assignments and projects where analysis of situations requires an in-depth evaluation of variable factors.
Provides 2nd level project management support and mentoring of fellow Clinical Data Managers and departmental users. Manage projects involving multiple teams. Exercises judgment in selection methods, techniques and evaluation criteria for obtaining results. Networks with key contacts outside own area of expertise.

You Will:

• 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.).

You Are:

• Comfortable working in a fast-paced environment.
• Able to hold yourself and others accountable in order to achieve goals and live up to commitments.
• An effective communicator, capable of determining how best to reach different audiences and executing communications based on that understanding.

You Have:

• 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 MS Office products.
• Experience and/or desire to learn working with various EDC systems: Medidata Rave, Caisis, InForm, etc.

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