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University of Miami · 11 hours ago

Manager, Clinical Research

Miami, FL

Full-time

Onsite

Senior Level

5+ years exp

The University of Miami is seeking a full-time Manager of Clinical Research to oversee the development of clinical trials and research programs. This role involves managing regulatory-related decisions, coordinating with study managers, and ensuring compliance with FDA regulations and clinical research best practices.

Higher Education

H1B Sponsor Likely

Responsibilities

Works with investigators and study teams to help meet targets and milestones, ensures timely and accurate submission to IRBs, sponsors and master agreements, and coordinates with the Research Program Director on remediation

Coordinates the efforts of relevant team members to manage, retain and control all applicable Regulatory Affairs submissions pertaining to University held INDs and IDEs as well as exemption requests

Assembles project plans, team and work assignments, directing and monitoring work efforts on a daily basis, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately

Manages investigator relationships

Maintains IND and IDE documentation, including annual reports for delegated studies and works with the primary investigator and project team to assist in responding to queries from regulatory agencies including the FDA

Tracks proposals and other study relevant documentation through signature/approval processes then through collaboration with Contracts and budgets

Serves as liaison and facilitates meetings between project stakeholders and leadership and completes and maintains professional documentation for projects and deliverables, develops SOPs as needed, and assists in the auditing and monitoring of studies

Identifies areas for improvement within daily functions, internal procedures, and regulatory agency interactions

Interacts with project team members to define submission logistics and workflow scheduling

Oversees the ongoing maintenance of records detailing the number of active INDs and IDEs and related data via an internal tracking system

Prepares and presents the annual summary report for clinical trial and research areas

Provides consultation and guidance for UM held INDs and IDEs

Develops, implements, maintains and oversees internal policies and SOPs as well as University‐wide policies and SOPs intended to assist University researchers in maintaining compliance with FDA regulations and other Clinical Research Best Practices

Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures. Ensures employees are trained on controls within the function and on University policy and procedures

Develops and oversees the financial operations of study coordinator service lines for CTRS/ MSOM investigators, encompassing regulatory and study management services for clinical research trials

Assists with developing initiatives to transform processes within the CTRS to enhance the clinical research enterprise

Participates in the design and execution of program improvement plans derived from annual evaluations of the clinical coordinator services of the CTRS

Promotes visibility/availability of the CTRS coordinator services throughout the institution

Helps to develop and operationalize clinical research coordinator services in the UHealth system

Ensures proper budgeting, invoicing, and payment for all individual study activities conducted by clinical research coordinators

Participates in human resources activities for direct reports, including recruiting and selection, hiring and termination, training, development, mentoring, counseling, performance evaluations, and providing recommendations to CTRS leadership

Conduct meetings with research staff and ensure functions are coordinated promptly and accurately

Responsible for the design, execution, and effectiveness of a system of internal controls that provides reasonable assurance that operations are effective and efficient, assets are safeguarded, and financial information is reliable and compliant with applicable laws, regulations, policies, and procedures

Develop and maintain a set of metrics to drive the decision-making process for CTRS needs and track productivity

Analyzes reports, data briefs, and auxiliary publications for new topic modules

Participate in relevant committees to provide clinical research expertise and guidance

Establishes and continuously assesses the effectiveness of the SOPs within the CTRS and compliance with university policies and procedures

Performs other duties as assigned

Qualification

SOCRA certificationACRP certificationClinical research managementRegulatory Affairs knowledgeLeadership skillsCommunication skillsBusiness principles knowledgeStrategic planningTrainingDevelopmentTeam management

Required

Master's degree in relevant field preferred

SOCRA or ACRP certification is required

Five (5) years of experience managing an extensive clinical research program or project is required

Exceptional leadership and communication skills with experience in clinical research development

Knowledge of business and management principles

Ability to direct, manage, implement, and evaluate department operations

Ability to establish department goals, and objectives that support the strategic plan

Ability to effectively plan, delegate and/or supervise the work of others

Ability to lead, motivate, develop, and train others

Benefits

Medical

Dental

Tuition remission

And more

Company

University of Miami

Glassdoor3.9

At UM you'll join a diverse and energized academic community.

Founded in 1925

Coral Gables, fl, US

5001-10000 employees

http://miami.edu

H1B Sponsorship

University of Miami 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 (137)

2024 (153)

2023 (150)

2022 (122)

2021 (95)

2020 (114)