Program Manager-Clinical Trials
Mount Sinai Health System
**Job Description**
The Program Manager is a senior operational and financial strategist responsible for accelerating the lifecycle of industry-funded clinical trials. Reporting to the FACTS Office leadership, you will serve as the primary liaison between clinical and research departments and industry sponsors to ensure rapid trial start-up and rigorous fiscal stewardship.
As part of the FACT Office, this role serves as a central program manager across research administration, contracts, finance, compliance, and assigned clinical or research departments to ensure efficient project start-up activation, transparent financial oversight, and adherence to institutional and sponsor requirements.
The ideal candidate is metric driven that combines strong program management skills with deep knowledge of clinical research activation, finance and workflows. Must have expertise in reviewing protocols/consent forms, creating and negotiating budgets, budget forecasting, monitoring subject enrollment, account reconciliation, and financial reporting.
**Qualifications**
+ Bachelor?s Degree Required Master?s Degree Preferred
+ Minimum of 5 years of experience in clinical research, including managing investigator-initiated trials preferred.
+ Progressive managerial related experience specific to area of responsibilities preferably in the areas of project management, change management, health care delivery re-design or integration, health policy reform.
+ Certification in clinical research specialty area preferred.
+ Effective written and oral communication skills
+ Effective interpersonal skills; able to establish good working relationships and collaborate with networks of employees of all levels; able to foster cooperation in others; creative problem-solver.
+ Ability to foster a collaborative, supportive, and high-performance team environment.
+ Hybrid work environment with occasional travel required.
+ Flexible schedule to accommodate project deadlines and stakeholder needs.
Non-Bargaining Unit, 820 - Clinical Trials Unit - ISM, Icahn School of Medicine
**Responsibilities**
+ **Accelerated Project Start-Up & Operational Leadership**
+ Site Activation: Coordinate the end-to-end site readiness process, concurrent contract and budget negotiations alongside IRB review to meet aggressive "first-patient-in" deadlines.
+ Regulatory Oversight: Facilitate CTO Teams Site Qualification Visits (SQV) and ensure all Site Initiation Visit (SIV) requirements are met in compliance with Mount Sinai Good Clinical Practice (GCP) and institutional standards.
+ Translational Coordination: Manage logistics for translational medicine assets, ensuring specimen collection, CTO Teams data entry into Mount Sinai databases, and biomarker transfers align with industry protocol specifications.
+ **Specialized Finance Administration (Pre and Post Award)**
+ Budget Development: Lead negotiation of industry-sponsored budgets, ensuring the inclusion of all Icahn School of Medicine institutional and FACTS-specific fees.
+ Coverage Analysis: Oversee FACTS Services Medicare Coverage Analysis (MCA) to differentiate billable patient care costs from research-funded procedures.
+ Post-Award Revenue: Manage FACTS Financial Management payment remittances, milestone tracking, and invoicing through the Mount Sinai Clinical Trial Management System (CTMS), ensuring all industry wire payments are correctly routed to FACTS.
+ Metrics: Monitor post-award financial performance, including invoicing, payments, cost recovery, and reconciliation
+ **Stakeholder Engagement & Compliance Management**
+ Sponsor Liaison: Act as the primary contact for pharmaceutical and biotech sponsors, delivering status reports on metrics and financial performance.
+ Policy Compliance: Maintain expert knowledge of institutional policies regarding for-profit clinical research, ensuring all agreements align with Mount Sinai's legal and ethical standards.
+ Quality: Develop and maintain program documentation, SOPs, and guidance materials.
+ **Qualifications**
+ Education: Bachelor’s degree required; Master’s degree in Life Sciences, Business, or Research Administration preferred.
+ Experience: 5+ years of experience in Clinical Research Manager, clinical trials management, specifically focused on industry-funded studies and pre and post award finance administration.
+ Ability to manage multiple complex projects simultaneously and meet deadlines.
+ Demonstrated experience with clinical trial budgeting, financial feasibility, invoicing.
+ Strong understanding of clinical research regulations and institutional workflows.
+ Experience managing or supporting expedited study start-up (FASTtrack)
+ Familiarity with IRB, contracts, coverage analysis, and clinical billing compliance.
+ Proficiency with clinical trial management systems (OnCore), financial systems (Oracle CLOUD), EHR (Epic) and other reporting tools and dashboards (Tableau).
+ Provides administrative services and analytical support to management with experience using Microsoft 365 including Word, PP, Excel, Copilot, and other platforms including ChatGPT, Smartsheet, etc.
+ Excellent organizational, analytical, and communication skills
+ Hybrid opportunity (Mount Sinai Main Campus & 42 nd Street Corp Office)
**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 $85000 - $117053.18 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.
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