Mount Sinai Careers
CLINICAL TRIALS MANAGER - The Department of Tisch Cancer Institute
Ground breaking science. Advancing medicine. Healing made personal.
Roles & Responsibilities:
The Clinical Trials Manager (CTM) of the GU/LUNG Programs, will be responsible for overall conduct of clinical trials using Good Clinical Practice under the Cancer Clinical Trials Office (CCTO). The CTM will coordinate and manage multiple clinical trial projects and protocols, including federally funded studies, investigator-initiated studies, and/or those from pharmaceutical companies. The manager instructs and trains staff regarding all protocols requirements; provides support for ongoing research projects and provides administrative oversight and guidance regarding staff roles and regulatory submissions for each study.
Duties and Responsibilities:
- Manages and coordinates clinical trial and related research studies conducted by the principal investigator(s) to ensure conformance with specified research objectives and protocols
- Coordinates and establishes clinical trial schedules, task assignments and allocation of staff
- Oversees 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
- Ensures 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
- Serves as the primary liaison with pharmaceutical companies for industry-sponsored clinical trials. Provides updates on status, adverse side effects and trends, evaluates patient enrollment and provides appropriate recommendations and/or conclusions
- Assists the Principal Investigator in developing the protocol budget. Also may include monitoring and reconciling budgets and other financial items for clinical trials and tracking reimbursements from sponsoring parties
- Develops policies and procedures for administrative oversight of clinical trials; conducts regular meetings with staff to ensure compliance with established practices and to keep employees abreast of current standards and policies
- Manages and monitors clinical trials which the principal investigator is responsible for including recruitment and management of subject enrollment
- Assists with various personnel functions such as hiring, performance appraisals, coaching, disciplinary actions and terminations. Provides guidance and support to staff and orients and mentors new research team members
- Assist Investigator(s) with developing IITs and preparing manuscripts for publications
- Assumes responsibilities for data management and compliance for entire portfolio. Maintains schedules and procedures necessary for timely and complete data collection
- Performs other related duties, as appropriate.
This position reports into the Executive Director of Clinical Research Administration within the Tisch Cancer Institute and the Medical Director of the Cancer Clinical Trials Office.
- Bachelor’s Degree in Nursing, Biology, Public Health or related scientific/ health field, Masters Preferred
- 6 years of experience managing clinical trials, including 2 years in management/ leadership role
The Mount Sinai Health System
believes that diversity is a driver for excellence. We share a common devotion
to delivering exceptional patient care. Yet we’re as diverse as the city we
call home- culturally, ethically, in outlook and lifestyle. When you join us,
you become a
part of Mount Sinai’s unrivaled record of achievement, education and advancement as we revolutionize medicine together.
We work hard to acquire and retain the best people, and to create a welcoming, nurturing work environment where you can develop professionally. We share the belief that all employees, regardless of job title or expertise, can make an impact on quality patient care.
Explore more about this opportunity and how you can help us write a new chapter in our story!
Over 38,000 employees strong, the mission of the Mount Sinai Health System is to provide compassionate patient care with seamless coordination and to advance medicine through unrivaled education, research, and outreach in the many diverse communities we serve.
Formed in September 2013, The Mount Sinai Health System combines the excellence of the Icahn School of Medicine at Mount Sinai with seven premier hospital campuses, including Mount Sinai Beth Israel, Mount Sinai Beth Israel Brooklyn, The Mount Sinai Hospital, Mount Sinai Queens, Mount Sinai West (formerly Mount Sinai Roosevelt), Mount Sinai St. Luke’s, and New York Eye and Ear Infirmary of Mount Sinai.
The Mount Sinai Health System is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, background, or sexual orientation.