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Company Overview

The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe.

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Job Description

Exciting opportunity at MSK: Join our team as a Clinical Data Standards Manager, Prostate Cancer Clinical Trials Consortium (PCCTC)! We're looking for a dynamic and highly motivated professional to support our clinical research team.

Role Overview:

• eCRF Design:
• Lead the design and development of electronic Case Report Forms (eCRFs) that are aligned with the study protocol.
• Collaborate closely with clinical study teams to translate protocol requirements into a fully functional eCRF, ensuring all critical data points are captured efficiently.
• Optimize eCRF layout for both ease of use and data quality.
• CDISC/CDASH Standards:
• Ensure adherence to CDISC and CDASH standards in eCRF design, database structures, and all data collection processes.
• Lead initiative to build, maintain, and implement CDASH compliant prostate cancer CRF library.
• Study Start-Up Activities:
• Coordinate database development, configuration, and testing during study start-up.
• Lead user acceptance testing (UAT) to ensure the database is fully operational before study launch.
• Set up and manage clinical coding systems (e.g., MedDRA, WHODrug).
• Clinical Data Management and Data Standards:
• Align the database with global data standards, supporting high-quality data collection and adherence to regulatory guidelines.
• Collaborate with multi-functional teams to maintain data consistency and integrity throughout the study.
• Work alongside Biostatistician and Data Science to ensure data flow from entry to analysis.

Key Qualifications:

• Background in Life Sciences, Computer Science, or a related field.
• 5+ years of experience in Clinical Data Management, with a focus on eCRF design, database building, and study start-up.
• Expertise in CDISC/CDASH standards and experience building databases from clinical protocols.
• Deep understanding of oncology, with knowledge of prostate cancer highly preferred.
• Experience with major EDC systems (e.g., Medidata RAVE, Oracle InForm, Veeva).
• Solid background in clinical database standards and their application in study start-up and data management.
• Knowledge of clinical coding systems (e.g., MedDRA, WHODrug).
• Experience in prostate cancer clinical trials is preferred.

Core Skills:

• Outstanding attention to detail and strong analytical and interpersonal skills.
• Planning and prioritizing work to meet commitments aligned with organizational goals.
• Critical thinking and problem-solving to ensure unforeseen issues are handled appropriately and resolved in a timely fashion.
• Superb communication skills and the ability to communicate effectively across all levels in a confident, professional manner.
• Understanding of global data standards, including SDTM, and how they apply to clinical database development.
• Familiarity with SQL, SAS, R, or similar for data handling and management.

Additional Information:

• Location: Remote
• Schedule: Mnday to Friday
• Reporting to Director, Clinical Data Management

Pay Range: $98,500 - $157,600

Helpful Links:

• MSK Compensation Philosophy
• Review our great benefits offerings

Learn more about 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. To fulfill our mission, we developed a unique infrastructure which has fostered a culture of transparent project co-development between investigators, research sites and industry partners. Established as an independent entity in 2014, the PCCTC, LLC is now the nation's premier multicenter clinical research organization specializing in innovative prostate cancer research.

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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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