Associate Director of Operations Job at Mount Sinai Health System (New York)

Job Description

The Associate Director of Operations supports and oversees the daily operational, administrative, and research activities of the department. This role provides leadership across staff supervision, retention, budgetary oversight, materials management, data management, and regulatory compliance to ensure the successful execution of clinical research programs. In collaboration with the Director and faculty leadership, the Associate Director advances the Center’s strategic growth through business development initiatives and the innovative use of technology, data analytics, and artificial intelligence (AI). The role is responsible for developing, implementing, and continuously improving departmental policies, procedures, and standard operating procedures (SOPs) to promote operational excellence, compliance, and scalability.

Job Responsibility

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

Requirements

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

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Associate Director of Operations

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