Senior Clinical Trials Manager, Cancer Institute - Tisch Cancer Institute

The Tisch Cancer Institute is a vital component of the Icahn School of Medicine at Mount Sinai Hospital and plays a key role in the Mount Sinai Health System, which is one of the largest health care systems in the nation.   We are a National Cancer Institute (NCI)-designated center and provide a multidisciplinary approach to cancer treatments and clinical breakthroughs that may one day put an end to cancer.  

• 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.
• Identifies gaps in the clinical trial portfolio and networks with pharmaceutical/biotech companies to fill voids.
• Mentors junior staff (clinical research coordinators, research program coordinators) to foster career growth
• Participates in the onboarding of new clinical trial managers and acts as a central resource during orientation period.
• Participates in Department level committees.
• 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.
• May play a role in monitoring and reconciling budget 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.
• Organizes grant submissions and implements standard operating procedures for clinical monitoring. Manages and monitors all sites involved in multi-site 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 multi-institutional trial set up to coordinate, facilitate, and perform basic and clinical research.
   

• Bachelor's Degree in Biology, Public Health or related scientific/health field; Masters preferred
• 3 years in leadership role with direct supervisory experience
• 4 years of experience managing clinical trials; prior experience with clinical trial budget development and start-up process required.
• ACRP or SOCRA certification strongly preferred

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About the Mount Sinai Health System:

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading scho