Clinical Trials Manager

3 weeks ago

New York, New York, United States Mount Sinai Health System Full time

Clinical Trials Manager Job Summary

The Mount Sinai Health System is seeking a highly skilled Clinical Trials Manager to coordinate and manage multiple clinical trial projects and protocols. This role will oversee the coordination of clinical trials, including federally funded studies, investigator-initiated studies, and those from pharmaceutical companies.

Key Responsibilities:

  • Coordinate and manage clinical trial projects and protocols
  • Oversee the coordination of clinical trials, including federally funded studies, investigator-initiated studies, and those from pharmaceutical companies
  • Provide administrative oversight and guidance regarding staff roles and regulatory submissions for each study
  • Manage and coordinate clinical trial and related research studies conducted by the principal investigator(s) to ensure conformance with specified research objectives and protocols
  • Coordinate and establish clinical trial schedules, task assignments, and allocation of staff
  • Oversee the status of all subjects enrolled in clinical trials, including completion and tracking of all required regulatory documents, including the appropriate reporting of all SAEs
  • Ensure clinical research studies are conducted according to good clinical practices, specified research protocols, and requirements of the Icahn School of Medicine at Mount Sinai, outside sponsors, and all federal and/or state regulatory agencies
  • Serve as the primary liaison with pharmaceutical companies for industry-sponsored clinical trials
  • May play a role in monitoring and reconciling budget and other financial items for clinical trials and tracking reimbursements from sponsoring parties
  • Develop policies and procedures for administrative oversight of clinical trials; conduct regular meetings with staff to ensure compliance with established practices and to keep employees abreast of current standards and policies
  • Organize grant submissions and implement standard operating procedures for clinical monitoring
  • Manage and monitor all sites involved in multi-site clinical trials which the principal investigator is responsible for, including recruitment and management of subject enrollment
  • Assist with various personnel functions such as hiring, performance appraisals, coaching, disciplinary actions, and terminations
  • Provide guidance and support to staff and orient and mentor new research team members

About the Mount Sinai Health System

The Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education.

The Health System includes approximately 7,400 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers.

The Mount Sinai Health System is an equal opportunity employer. We comply with applicable Federal civil rights laws and does not discriminate, exclude, or treat people differently on the basis of race, color, national origin, age, religion, disability, sex, sexual orientation, gender identity, or gender expression.

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