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 Senior 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.
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.).
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.
5 years or more of clinical data management and clinical research experience or as determined by hiring manager.
A Bachelor's degree is preferred, or 4 years of job-related work experience can be accepted.
Certified Clinical Data Manager Certification (CCDM) preferred.
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 with SQL/SAS/Business Objects, any reporting tools and programing languages preferred.
Experience working in an FDA regulated environment a plus.
Experience and/or desire to learn working with various EDC systems: Medidata Rave, Caisis, InForm, etc.
Internal Number: 2020-39589
About Memorial Sloan-Kettering Cancer Center
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and 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.