NYU GROSSMAN SCHOOL OF MEDICINE is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the Grossman School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care. For more information, go to med.nyu.edu, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, Twitter and Instagram.

POSITION SUMMARY:

We have an exciting opportunity to join our team as a Clinical Data Manager. 

We have an exciting opportunity to join our EPPIC-Net team as a Clinical Data Manager.

EPPIC-Net is a network that includes a Data Coordinating Center (DCC), Clinical Coordinating Center (CCC), and ten Specialized Clinical Centers (SCCs). The DCC works with Federal government partners to conduct high-quality efficient clinical trials to develop non-addictive treatments for pain as part of the Helping to End Addiction Long-term (HEAL) initiative. The DCC provides a range of coordinating services for this NIH-funded network, including statistical and data management; collection of clinical, biomarker and imaging data; and establishment of repositories for biospecimens and biomedical images.

This individual will be joining NYULMCs DataCore, an innovative organization that utilizes state-of-the-art technologies and informatics products to meet the clinical research needs of a prestigious institution. NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical history and enrich the lives of countless people. An integral part of NYU Langone Health, the School of Medicine at its core is committed to improving the human condition through medical education, scientific research, and direct patient care The Data Manager (DM) will review clinical study data to assure accuracy, timeliness and completeness. The DM will assure the clinical research databases are in accordance with GCP, FDA guidelines and institutional SOPs to assess the safety and efficacy of Investigational Product or therapeutic treatment. The Data Manager works with a highly specialized team to move clinical trials from inception to completion, from protocol development to locking the database and packaging the data for the study statistician. The DM is expected to manage the study through these phases in a timely and professional manner while adhering to the established clinical trial and regulatory standards and the financial constrictions. The DM will have the responsibility of coordinating all data from EPPIC-Nets large, multi-site clinical trials.

JOB RESPONSIBILITIES:

• Maintain Data Management Plan
• Understand the clinical research process and associated procedures
• Working with the study team, design and develop Case Report Forms, in collaboration with the eCRF Programmer
• Test and validate the programming of electronic data capture (EDC) systems, registries, web sites and other informatics systems, products, and integration
• Develop specifications and where possible, program reports for monitoring studies, project reporting, and analysis of clinical trial data
• Coordinating data collecting from multiple sources including EDC data extraction, data from external vendors, e.g. central laboratories
• Reconcile data from multiple data sources and resolve any discrepancies
• Review study data to ensure timeliness, completeness and accuracy to have the highest possible level of research study data integrity
• Develop data queries for any questionable data and monitor the accurate and complete resolution of all data queries
• Monitor clinical site efficiency and effectiveness in data capture, data management and data integrity monitoring
• Manage user request for systems modifications and report development
• Troubleshoot system/software problems through resolution
• Train users on the operation of systems, tools and data management/data integrity monitoring procedure
• Ensure that external and internal regulations and policies governing data management and data systems are met including but not limited to GCP, FDA and organizational SOPs
• Work closely with the Principal Investigator and research team and participate in team conferences and meetings.
• Develop policies and procedures and best practice methodologies
• Work with information technology staff and others to facilitate automation of standard, recurrent data acquisition, management, analysis, and reporting
• Assist in the development of methodologies to conduct data tracking and quality assurance Assist in establishing data standards
• Participate in development of long range planning for new projects and facilities, serve in an advisory capacity on database procedures and methods

MINIMUM QUALIFICATIONS:

To qualify you must have a Bachelors degree in Computer Science, Health Sciences or related field with 2-6 years related experience Must possess a working knowledge of research processes, clinical operations and data quality management Experience in conducting clinical research data management Strong attention to detail and skill with numbers Experience with programming languages including the creation of data entry and query screens/processes and data quality checks Knowledge and experience with electronic data capture (EDC) and database management systems Proficiency in office automation programs, including but not limited to work processing, spreadsheets, etc. Demonstrated analytical and problem solving skills Ability to manage multiple projects, tasks and priorities to achieve desired goals Experience in training users in operation of software and tools Ability to exercise judgment, initiative, and resourcefulness in making decisions consulting with clinical research personnel Ability to multitask, work independently with minimal supervision and proceed without a great deal of direction Ability to work with multiple all levels of personnel with varying degrees of technical expertise Demonstrated strong teamwork and organizational skills, and outstanding interpersonal skills Independent judgment and prioritization skills Excellent written and oral communication

Qualified candidates must be able to effectively communicate with all levels of the organization. NYU Grossman School of Medicine 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. NYU Grossman School of Medicine 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, sex, sexual orientation, transgender status, gender dysphoria, national origin, age, religion, disability, military and veteran status, marital or parental status, citizenship 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 Grossman School of Medicine's EEO policies, please click here. Please click here to view the Federal "EEO is the law" poster or visit https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm for more information. To view the Pay Transparency Notice, please click here.

Required Skills Required Experience