NYU Langone Medical Center, a world-class, patient-centered, integrated, academic medical center, is one of the nation's premier centers for excellence in clinical care, biomedical research and medical education. Located in the heart of Manhattan, NYU Langone is composed of four hospitals - Tisch Hospital, its flagship acute care facility; Rusk Rehabilitation; the Hospital for Joint Diseases, one of only five hospitals in the nation dedicated to orthopaedics and rheumatology; and Hassenfeld Children's Hospital, a comprehensive pediatric hospital supporting a full array of children's health services across the medical center - plus the NYU School of Medicine, which since 1841 has trained thousands of physicians and scientists who have helped to shape the course of medical history. The medical center's tri-fold mission to serve, teach and discover is achieved 365 days a year through the seamless integration of a culture devoted to excellence in patient care, education and research. For more information, go to www.NYULMC.org.
We have an exciting opportunity to join our team as a Clinical Data Manager.
The Clinical Data Manager (DM) will be joining NYULMC's DataCore, an innovative organization that utilizes state-of-the-art technologies and informatics products to meet the clinical research needs of a prestigious institution. This position will work with highly specialized and cross-functional teams to shepherd clinical trials from inception to completion, starting from developing protocols through locking study databases and packaging data for final analyses, as well as play a key role in ensuring the timely completion of assigned studies while adhering to established clinical trial standards and study budgets. In particular, this position will ensure that clinical research databases are built and maintained in accordance with Good Clinical Practices (GCP), Food and Drug Administration (FDA), Clinical Data Interchange Standards Consortium (CDISC) guidelines, and institutional SOPs, and will coordinate all data transfers from small single site studies to large, multi-site clinical trials. In addition, this position will review clinical study data to ensure accuracy, timeliness, and completeness, and will provide input into technical initiatives to develop and continuously improve internal Clinical Data Management processes. The successful candidate will be familiar with study protocols, data management plans, annotated case report forms (CRFs), and data transfer agreements of assigned studies to ensure completion of study tasks in accordance with clinical trial documentation, and will also liaise with external data vendors (e.g. Research Partners) as necessary to ensure that study-related data are transmitted in the required format.
- Develop and maintain Data Management Plans (DMP) and develop clinical research data flow specific to assigned studies.
- Develop specifications and where possible, prepare data matrices, operational reports, and analyses of clinical trials data.
- Train users on data entry guidelines for CRFs.
- Test and validate electronic data capture (EDC) systems, registries, web sites, and other informatics systems and products; test and document accuracy of processing, storage, and querying of variables in all electronic data capture (EDC) and web systems prior to use in studies.
- Review all modifications to CRFs and study databases at all phases of development; conduct quality assurance testing when changes are made to study databases.
- Ensure highest possible level of research study data integrity by reviewing study data for completeness and accuracy; initiate data queries and oversee data query resolution from initiation through completion.
- Ensure compliance with external and internal regulations and policies governing data management and data systems, including but not limited to GCP, FDA, CDISC, and organizational SOPs.
- Develop and conduct training on data management policies, procedures, and best practices; assist in developing SOPs for data tracking and quality assurance and in establishing and/or implementing data standards (e.g., CDASH, SDTM).
- Design and develop CRFs and data dictionaries; revise CRFs and supporting data dictionaries in compliance with SOPs and regulatory requirements; document changes to CRFs and schedules of assessment.
- Administer and maintain user access to study databases and restore access to and functioning of study databases in the event of service interruptions; manage user request for systems modifications and reports development.
- Troubleshoot system/software problems through resolution. Collaborate with NYULMC's MCIT Research staff in developing and implementing specifications to automate programs for recurring data extraction, transformation, analysis, and reporting needs.
- Work closely with Principal Investigators and study teams; participate in study-related conferences, as necessary.
- Participate in development of strategic plans for new projects and facilities, serve in an advisory capacity on best practices for database development and maintenance.
- Must have a Bachelor's degree in Computer Science, Health Sciences or related field with 3-6 years related experience.
- Must have a working knowledge of clinical trials research processes, clinical operations, and data management.
- Experience in conducting clinical research data management.
- Strong attention to detail and demonstrated proficiency in quantitative and qualitative analyses.
- Experience with programming languages including the creation of data entry and query screens/processes and data quality checks.
- Knowledge of and experience with electronic data capture (EDC) and database management systems.
- Proficiency in office automation programs, including but not limited to word processing, spreadsheets, etc.
- Ability to manage multiple projects, tasks, and priorities; work independently with minimal supervision and execute tasks to completion without a great deal of direction.
- Experience in training users in operation of clinical trials systems and tools.
- Ability to exercise judgment, initiative, and resourcefulness in making decisions in consultation with clinical research personnel, and independently if necessary.
- Ability to work with personnel who have varying degrees of technical expertise.
- Demonstrated strong teamwork and organizational skills; outstanding interpersonal and communication skills.
- Experience with EDC software such as REDcap and other commercial systems (e.g., Medidata, Inform, TrialMaster, Velos, etc.).
- Certified Clinical Data Manager (CCDM) credential desired.
- CCDM certification a plus.
Qualified candidates must be able to effectively communicate with all levels of the organization.
NYU Langone Medical Center provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents. And just as our employees invest so much in us, we invest in our employees. We're pleased to have one of the most competitive compensation packages not only among New York's hospitals and healthcare institutions, but within the corporate sector as well. We begin with exceptional medical, dental, and drug coverage. We enhance this basic coverage with comprehensive wellness programs, and supplement those with retirement investment and benefits plans, and generous paid time off allowances. Add to that a very attractive tuition program, and you'll see just some of the ways that NYU Langone Medical Center demonstrates our commitment to our employees.
NYU Langone Medical Center 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, military and veteran status, genetic information or any other factor which cannot lawfully be used as a basis for an employment decision.
We require applications to be completed online.
If you wish to view NYU Langone Medical Center's EEO policies, please click here. Please click here to view the Federal 'EEO is the law' poster or visit http://www1.eeoc.gov/employers/poster.cfm for more information.