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

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

The Mount Sinai Hospital is a leading academic medical system in the New York metro area, and they are seeking an Associate Director of Operations to oversee daily operational and administrative activities within the Center for Interventional Cardiovascular Research and Clinical Trials. This role involves providing leadership in staff management, budget oversight, and ensuring compliance with regulatory standards while driving strategic growth and innovation in clinical research programs.

Hospital & Health Care
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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 ComplianceBudget ManagementData AnalyticsStaff SupervisionProject ManagementPublic HealthBusiness AdministrationCollaborationCommunication

Required

Bachelor's degree in public health/administration or business or a related field or equivalent education and experience
5 years of experience in a professional business environment, with health related and project management experience
Supervisory experience is a plus
1 year in CRO, Pharma, Biotech or ARO

Preferred

Masters (MPA, MPH, MBA or related)

Company

The Mount Sinai Hospital

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The Mount Sinai Hospital is one of the nation's oldest, largest, and most respected hospitals, and a member of the Mount Sinai Health System.

H1B Sponsorship

The Mount Sinai Hospital 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 (110)
2024 (66)
2023 (71)
2022 (84)
2021 (45)
2020 (44)

Funding

Current Stage
Late Stage

Leadership Team

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Michael Pastier
Senior Vice President / Chief Financial Officer
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Scott Lorin, MD, MBA
President, Chief Operating Officer
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Company data provided by crunchbase