Senior Clinical Trials Manager - Tisch Cancer Institute

Strength Through Diversity Ground breaking science. Advancing medicine. Healing made personal. 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. Roles & 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. 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. Requirements: Bachelor's Degree in Biology, Public Health or related scientific/health field; Masters preferred. ACRP or SOCRA certification preferred; required with 18 months of employment 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. Strength Through Diversity The Mount Sinai Health System believes that diversity, equity and inclusion are drivers 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 and participate actively as a leader within the Mount Sinai Health System by: Serving as the primary resource management representative of the Mount Sinai leadership teams, committees, etc., and acting as the primary executive leader interface between Mount Sinai and key executives from the health systems’ vendors and partners. Engaging with relevant thought leaders and policy-makers at the federal and state levels, and representing the Health System as assigned. Using a lens of equity in establishing and promoting policies and procedures and providing opportunities for all to thrive. Confronting racist, sexist or other inappropriate behavior and challenges exclusionary organizational practices and serving as a role model to promote anti-racist behaviors. Inspiring and fostering an environment of anti-racist behaviors among and between departments and co-workers. 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! Who We Are Over 42,000 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 Morningside (formerly 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 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. EOE Minorities/Women/Disabled/Veterans Compensation The 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 $96,461.00 - $144,692.00 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.