Clinical Data Manager - Prostate Cancer Clinical Trials Consortium (Pcctc)

Memorial Sloan-Kettering Cancer Center New York , NY 10007

Posted 3 weeks ago

Company Overview

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. For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker's Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor's Employees' Choice Best Place to Work for 2018. We're treating cancer, one patient at a time. Join us and make a difference every day.

Job Description

Prostate Cancer Clinical Trials Consortium (PCCTC)

We are a 13-member clinical research group, with its Coordinating Center headquartered at Memorial Sloan Kettering Cancer Center.

In the PCCTC, we work together on a single mission: to design, implement, and complete hypothesis-driven phase I and phase II trials in prostate cancer, translating scientific discoveries to improved standards of care for patients.

We are 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.

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:

  • 2 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 in SQL and MS Office products.

  • 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.

Closing

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.


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Clinical Data Manager - Prostate Cancer Clinical Trials Consortium (Pcctc)

Memorial Sloan-Kettering Cancer Center