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. At NYU Langone Health, equity and inclusion are fundamental values. We strive to be a place where our exceptionally talented faculty, staff, and students of all identities can thrive. We embrace inclusion and individual skills, ideas, and knowledge. 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 Program Manager. In this role, the successful candidate is responsible for providing a broad range of complex program coordination. Responsible for the development, promotion, direction and coordination of assigned programs including program design, budget and financial collections, staffing, logistics and other supportive functions as assigned. Direct oversight of data entry/coordination and regulatory compliance for assigned programs. Facilitates research programmatic activities including the recruitment and onboarding of new staff, training and education of all direct reports and tracking of work completed for budgetary purposes. Serves as a liaison to the Clinical Trials Office Business Operations Unit to ensure appropriate invoicing and collections.Job Responsibilities:Project/Program Coordination:- Ensure regular research meetings with all stakeholders occur regularly and that research support staff are consistently prepared to present and communicate updates at such meetings.- Oversight of all data coordination and regulatory functions for assigned programs. Ensure appropriate workload and trial assignments for all support staff.- As needed, provides data coordinator and regulatory specialist support to investigators especially when there are competing deadlines.- Facilitate movement of study documents to long-term storage for all assigned programs.Track long-term storage items until time of destruction.- Liaison with the Quality Assurance and IIT support unit to ensure efficient setup of and conduct of all new IITs, and to ensure appropriate preparation and response to internal or external audits.- Overseeing timelines regarding submission of study amendments including changes to the protocol, consent forms and other study documents.- Ensuring there is accurate preparation of annual renewals & study closure for IRB & sponsors.- Participate in presenting at Data Coordination Unit Meetings and Regulatory Affairs Unit Meetings ensuring one relevant training per month. Trainings should focus on federal regulations governing the conduct of human subjects research and should be dictated by Quality Assurance Unit findings at least quarterly.- Respond to monitor complaints ensuring rapid resolution and maintain good working relationships with study sponsors and clinical research organizations.- Ensure Clinical Trials website is up to date and that all content is uploaded per investigator and DMG leader approval.- Facilitate internal and external audits; ensuring CAPA is completed.- Participate in the internal audit committee bi-annually.- Perform route cause analysis for any deviations/compliance issues.- Participate in workgroups and strategic initiatives.Reporting:- Provide monthly change of monitor report to PCC-BOU@nyumc.org.- Track resourcing needs at DMG review using CTO defined complexity scores and standard staffing formulas. Submit workload analysis and resource requests to CTO Administrative Director.- Maintain attendance sheets for DMG and Research Meetings and provide attendance rates to Administrative Director.- Ensure all critical fields within Research Navigator are complete and undergo QA review at least monthly.- Ensure standard reports are prepared for DMG meetings showing status of data entry for full DMG portfolio.- Ensure Research Coordinators are tracking data locks.- Enter DMG reviews in DMG activity tracker.- Prepare additional reports for PCC leadership.- Collaborate directly with the Senior Regulatory Specialists (Pre-activation) to help prioritize and support the submission and activation of clinical trials.- Attend all pipeline related meetings and provide status updates at DMG meetings, including the communication of activation timelines.Staff Management:- Provide direct supervision, training and mentorship to all Research and Snr. Research Coordinators and Regulatory Specialists within assigned program(s).- Ensure research coordinators and regulatory specialists are trained according to CTO defined Standard Operating Procedures and training program.- Mentor direct reports on all behavioral competencies.- Recruitment and onboarding for open Research Data Associates, Research Coordinators and Senior Research Coordinator positions and Regulatory Specialists within assigned program(s).Minimum Qualifications: To qualify you must have a Bachelors degree in business administration, healthcare administration or related field. Minimum of 4 years of progressively responsible related experience including program/project coordination expertise (within 2 areas of clinical research) or equivalent combination of education and experience. Proficiency in using various Microsoft Office applications such as Word, Excel, Access, Power point and Outlook. Familiar with internet applications. Effective oral and written communication skills, interpersonal skills, and organizational skills. Ability to interface effectively with all levels of management and must work and communicate effectively with both internal and external customers. Ability to work within a team environment as well as independently. Time management skills and ability to work well under pressure. Ability to multi task and manage projects.Preferred Qualifications: Masters Degree in Business Administration, Healthcare Administration or related field. CCRC or CCRP certification. Experience in both data management and regulatory or quality assurance.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. At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family. NYU Grossman School of Medicine is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online. View NYU Grossman School of Medicine's Equal Employment Opportunity (EEO) policy. Know Your Rights: Workplace discrimination is illegal.NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $81,325.15 - $120,393.00 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.To view the Pay Transparency Notice, please click hereNYU 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, 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.

Minimum Salary: 81325.15 Maximum Salary: 120393.00 Salary Unit: Yearly