Regulatory Research Project Manager - Early Drug Development Service
Memorial Sloan-Kettering Cancer Center
Location: New York, New York
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.
As one of the world's premier cancer centers, Memorial Sloan-Kettering Cancer Center is committed to exceptional patient care, leading-edge research, and superb educational programs. The close collaboration between our physicians and scientists is one of our unique strengths, enabling us to provide patients with the best care available today as we work to discover more effective strategies to prevent, control, and ultimately cure cancer in the future. Our education programs train future physicians and scientists, and the knowledge and experience they gain at Memorial Sloan-Kettering has an impact on cancer treatment and the biomedical research agenda around the world.