Regulatory Research Project Manager - Early Drug Development Service
Memorial Sloan Kettering Cancer Center
Location: New York, New York
Academic / Research
Internal Number: 2021-52967
At MSK, were running one of the largest clinical trials programs for cancer in the country, and at any time we are conducting hundreds of clinical trials to improve cancer care. We have a Regulatory Research Project Manager opportunity in our Early Drug Development service in the Department of Medicine. As an integral member of the research team, you will lead all tasks associated with the regulatory management of research protocols and study start-up management.
Supervise at least 5 Research Regulatory Associates (RRAs), each assigned to regulatory tasks on at least 12 therapeutic clinical trials
Prepare and submit new studies to the Protocol Activation Core (PAC) and ensure all the necessary study tools are completed prior to study activation
Ensure that all appropriate Institutional, State, and Federal regulations are followed throughout the course of a research project and/or database.
Perform quality checks of drafted deviations for reporting to the IRB/PB in regulatory compliance as appropriate, to supervisor.
Prepare waivers and data use agreements (as needed) for service research projects.
Collaborate with the service and/or Departmental PIs on the development of research database standard practices.
As needed, ensure that Serious Adverse Events (SAEs) are completed and reported to the SAE Manager in the IRB/PB, Office of Clinical Research and, if necessary, the sponsor.
Ensure proper submission of single patient use trials and exception letters to the IRB/PB.
Oversee audit and inspection readiness tasks performed by direct reports and other members of the team
A good decision-maker, with proven success at making timely decisions that keep the organization moving forward.
Focused on continuous improvement, knowing the most effective and efficient processes to optimize work flow.
Eager to foster talent and support people in meeting their career goals and the organization's goals.
Action-oriented and eager to embrace new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.
Exceptionally organized and demonstrated consistent success under pressure
A Bachelor's degree (preferred) with approximately 4-7 years of clinical research experience
At least one year of supervisory experience strongly preferred.
Knowledge of oncology-specific terminology is helpful.
Experience in the use of various electronic data management systems. Strong Data management skills, including database design preferred.
Basic knowledge of Microsoft suite (PowerPoint, Word, Access, Excel) and Teamshare.
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes. For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.