Manager, Clinical Research (Cardiology)

University of Miami•Miami, FL

11d

About The Position

The Department of Medicine, Cardiovascular Division at the Miller School of Medicine, University of Miami is seeking a highly motivated and experienced Manager, Clinical Research to lead and oversee the division’s clinical research support team. The ideal candidate will manage a dynamic team of clinical research coordinators (CRCs), ensuring efficient workload distribution and high-quality research operations. This role will involve closely analyzing the feasibility of potential clinical studies, ensuring that new studies are properly initiated, and directly overseeing the management and execution of clinical trials as needed. It will monitor recruitment targets and adherence to research compliance and University of Miami policies. The Manager, Clinical Research (A) oversees the development of clinical trials and research programs that support the overall mission of the University. This role is also responsible for the independent execution of regulatory-related decisions/strategies and coordinates work with study managers and other relevant team members to assure the fidelity of study protocols and data collection.

Requirements

Bachelor’s degree in relevant field required; Master's degree preferred
Minimum 5 years of relevant experience
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.

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.