Associate Director of Operations - Center for Interventional Cardiovascular Research and Clinical Trials jobs in United States
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Mount Sinai Health System · 2 days ago

Associate Director of Operations - Center for Interventional Cardiovascular Research and Clinical Trials

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, and they are seeking an Associate Director of Operations to support and oversee the daily operational, administrative, and research activities of the department. This role involves leadership across staff supervision, budgetary oversight, and regulatory compliance to ensure the successful execution of clinical research programs.

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H1B Sponsor Likelynote

Responsibilities

Lead all administrative operations, managing a multidisciplinary team supporting clinical trials, registries, and translational research
Provide day-to-day supervision of the Clinical Trial Management Team, Administration Team, and Catheterization Laboratory Research Team
Assist the Director in daily departmental operations and provide professional and administrative guidance to staff
Evaluate operational performance and identify opportunities for improvement; advise and inform the Director of administrative issues, needs, and risks
Plan, organize, and implement services to meet departmental goals and objectives
Develop, implement, and refine departmental policies, procedures, and SOPs to ensure efficiency, quality, and regulatory compliance
Oversee hiring, supervision, mentoring, evaluation, and retention of administrative and research staff
Foster a culture of accountability, inclusivity, collaboration, and professional development
Participate in interviewing and recommending candidates; assist with onboarding, orientation, mentoring, training, and probationary and annual evaluations
Recommend recognition, disciplinary actions, and termination when necessary
Maintain staff competencies through ongoing training and professional development initiatives
Ensure compliance with IRB, FDA, GCP, ICH, and institutional policies and standards
Review and assist with regulatory submissions, including IRB/IEC packages and continuing reviews
Conduct regular reviews of the Trial Master File (TMF) to ensure inspection readiness
Review monitoring visit reports and collaborate with monitors to address data quality, compliance trends, and site issues
Manage and coordinate assigned clinical research studies to ensure adherence to protocols, SOPs, and regulatory requirements
Coordinate clinical trial schedules, staff assignments, and subject management activities
Oversee subject enrollment, tracking, and completion of required regulatory documentation
Support study design, including review and/or development of protocols, informed consent forms (ICFs), and related study documents
Contribute to the development of Case Report Forms (CRFs)
Plan and conduct site evaluations, initiations, and routine monitoring visits; maintain strong relationships with clinical sites
Plan, organize, and present at investigator meetings
Serve as the primary point of contact for CROs and clinical vendors; provide study status updates, enrollment metrics, safety trends, and recommendations
Assist in the preparation, planning, and management of departmental and study budgets
Perform financial reconciliations, cost variance analyses, and budget justifications
Recommend and implement cost-effective operational strategies
Contribute to the development and negotiation of study budgets and contracts; ensure effectiveness of site budget and contract processes
Provide oversight and accountability for all third-party vendors
Drive cross-departmental collaboration to enhance research delivery, scalability, and impact
Collaborate with faculty and scientific leadership to identify emerging research opportunities and partnerships
Support investigators in preparing high-quality research submissions, including budgets, biosketches, letters of support, and compliance documentation
Manage the full proposal lifecycle, including feasibility assessments, RFP responses, bid defenses, and submissions
Leverage advanced data analytics, digital platforms, and AI-driven tools to streamline operations and improve decision-making
Champion predictive analytics, machine learning, and decision-support systems to optimize research performance and forecasting
Perform other related duties as assigned

Qualification

Clinical Research ManagementRegulatory ComplianceLeadershipBudget ManagementData AnalyticsProject ManagementStaff DevelopmentCommunicationCollaborationProblem Solving

Required

Bachelor's degree in public health/administration or business or a related field or equivalent education and experience

Preferred

Masters (MPA, MPH, MBA or related) is preferred
5 years of experience in a professional business environment, with health related and project management experience preferred
Supervisory experience is a plus; 1 year in CRO, Pharma, Biotech or ARO preferred

Company

Mount Sinai Health System

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Mount Sinai Health System delivers integrated medical care, research, and medical education through its network.

H1B Sponsorship

Mount Sinai Health System has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (26)
2022 (20)
2021 (6)
2020 (20)

Funding

Current Stage
Late Stage
Total Funding
$41.9M
Key Investors
National Institutes of HealthHearst Health Prize.Multiple Myeloma Research Foundation
2024-11-11Grant· $7M
2024-06-06Grant· $0.1M
2023-11-02Grant· $7M

Leadership Team

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Vincent Tammaro
Executive Vice President and Chief Financial Officer
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David Feinberg
Senior Vice President, Chief Marketing and Communications Officer
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Company data provided by crunchbase