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:
- Bachelor’s degree 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: Monday to Friday
- Reporting to Director, Clinical Data Management
Pay Range: $98,500 - $157,600
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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