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Job Description

As the Clinical Trials Manager, you 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 will instruct and trains staff regarding the requirements for all protocols; provides support for ongoing research projects and provides administrative oversight and guidance regarding staff roles and regulatory submissions for each study. This position reports into the Executive Director of Clinical Research Administration within the Tisch Cancer Institute.

The Clinical Trials Manager coordinates and manages multiple clinical trials projects and protocols, including those from pharmaceutical companies. This individual instructs staff regarding appropriate protocols; provides support for ongoing research projects and provides administrative oversight regarding staff roles and instructions for each study.

Qualifications

+ Bachelor's degree in Nursing, Biology, and Public Health or related scientific/health field, Masters preferred.

+ 6+ years of experience managing clinical trials, including 2 years in a management/leadership role

+ Preferred qualifications include:

+ Excellent written, oral and interpersonal skills

+ Demonstrated knowledge of clinical research concepts, good clinical practices and regulatory compliance

+ Proven ability to provide scientific and clinical expertise in all phases of clinical trials

+ Excellent analytical and problem solving skills

+ Strong management and leadership skills

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.

+ 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 with the coordination of the MPD Consortium, a NCI-sponsored program of 35 institutions in the United States and Europe, of which Mount Sinai is the lead site. The consortium focuses on understanding the biological foundations of the myeloproliferative neoplasms and using that understanding to develop hypothesis-generated therapeutic trials to improve the therapy of patients.

+ Assist Investigator(s) with developing IITs multi-institutional consortium set up to coordinate, facilitate, and perform basic and clinical research.

+ Support the logical operations of the liquid tumor tissue bank(s).

+ Performs other related duties, as appropriate.

About Us

Strength through Unity and Inclusion

The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai’s unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.

At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.

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 school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 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. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

Equal Opportunity Employer

The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.

Compensation Statement

Mount Sinai Health System (MSHS) provides a salary range to comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $104995 - $157492 Annually. Actual salaries depend on a variety of factors, including experience, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.