Details
Posted: 10-Jul-22
Location: New York, New York
Salary: Open
Categories:
Operations
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. We're treating cancer, one patient at a time. Join us and make a difference every day.
In compliance with applicable New York and New Jersey State regulatory authorities, COVID-19 vaccination (2 doses of either the Pfizer or Moderna vaccine or one dose of the Johnson & Johnson vaccine) is mandatory for all MSK employees, contingent workers, and volunteers. Exceptions are permitted for those employees who request and receive an approved medical or fully remote exemption.
*Staff working at a MSK New Jersey location must be up to date with COVID-19 vaccination, which includes having completed the primary COVID-19 vaccination series and booster once eligible as mandated by New Jersey State. All New Jersey staff not yet eligible for a booster must receive a booster within 3 weeks of becoming eligible as a condition of continued employment at MSK.
Note: Individuals are eligible to receive a COVID-19 booster five months after receiving the second dose of either the Pfizer or Moderna vaccine or two months after the J&J vaccine.
Job Description
The Prostate Cancer Clinical Trials Consortium is currently hiring an experienced Clinical Data Manager to join our dynamic clinical research team. Join us today and help make a difference every day!
The Prostate Cancer Clinical Trials Consortium (PCCTC) is the nation's premier multicenter Clinical Research Organization specializing in ground breaking prostate cancer research. We work together with distinguished investigators on a single mission: to design, implement and complete hypothesis-driven studies in prostate cancer, translating scientific discoveries to improved standards of care.
You will:
- Design Case Report Forms (CRFs) and provide database requirements and specifications, including field definitions, automatic edit checks, indication of critical variables and CRF completion guidelines.
- Assist in query design using SQL to check for missing or inconsistent eCRF data.
- Understand, update and optimize existing queries/reports.
- Correspond with investigator sites to obtain and track resolutions to queries.
- Analyze data to uncover potential issues/inconsistencies/areas of concern.
- Validate eCRF data (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 and regulatory guidelines.
- Maintain necessary clinical trial conduct documentation, including Data Management Plans.
You Are:
- Comfortable working in a fast-paced environment.
- Able to hold yourself and others accountable in order to achieve goals and meet commitments.
- An effective communicator, capable of determining how best to reach different audiences and communicating based on that understanding.
You Have:
- At least 2 years clinical data management experience and clinical research experience.
- Certified Clinical Data Manager Certification (CCDM) preferred.
- Comprehensive knowledge and understanding of 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 various EDC systems: Medidata Rave, Caisis, InForm, etc.
This is a full-time remote position with the possibility of occasional in-person meetings in New York City.
We believe in communication, openness, and thinking beyond your 8-hour day @ MSK. It's important to us that you have a sense of impact, community, and work/life balance. We want you to be and feel your best!
#LI-REMOTE
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.