Clinical Trials Manager

Clinical Trials Manager

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The Clinical Trials Manager is responsible for the coordination, implementation, and evaluation of all administrative aspects of clinical trial conduct, including feasibility, clinical research support, study prioritization, protocol review, study initiation, study maintenance, activation, and closeout activities. Directs and leads the development, implementation, and management of clinical trials processes in compliance with SOPs and relevant regulations. Identifies, tracks and analyzes barriers in current clinical trials processes, and recommends project management process improvements to the Leadership Team. Responsible for the management and administration of all aspects of the Heart and Vascular Center Clinical Trials program including planning, organizing, staffing, leading, and controlling program activities. This position plans the delivery of the overall program and its activities in accordance with the mission and the goals of the organization. This role will collaborate with Internal Medicine's Post-Award team on matters related to research compliance and financial management, ensuring adherence to sponsor requirements and institutional policies.

Required Skills and Abilities:

• Able to manage time effectively and work independently and within a team to meet objectives. Strong attention to detail and demonstrated skill working with minimal supervision.
• Able to hold self and others accountable in order to achieve time bound results. Flexible approach and ability to adapt to shifting demands of evolving priorities Focused on continuous process improvement and efficiency to optimize workflow.
• Demonstrated ability to provide proactive, flexible, and customer service focused communication and advice; work effectively with others. Demonstrated ethics and integrity in a professional matter, sensitivity to confidentiality, and a commitment to protecting research participants.
• Knowledge of Good Clinical Practice guidelines. Experience interpreting federal, state, local and sponsor policies and regulations.
• Strong computer skills required, including strong competency in Microsoft Office programs.

Principal Responsibilities:

• Oversees the advancement and growth of the program. Gives direction and leadership supporting the philosophy, mission, strategy, and annual goals and objectives.
• Plays a key role in strategic planning. Works closely with leadership, internal and external colleagues and community residents to develop new initiatives to support the strategic direction of the organization and implements long-term goals and objectives to achieve the successful outcome of the program.
• Develops an annual budget and operating plan to support the program. Ensures program operates within approved budget. Monitors and approves all budgeted program expenditures. Manages all program and project funds according to established accounting policies and procedures.
• Builds and maintains a program evaluation framework to assess the strengths of the program and to identify areas for improvement. Monitors the program activities on a regular basis and conducts an annual evaluation according to the program evaluation framework. Identifies and evaluates the risks associated with program activities and takes appropriate action to control the risks. Reports evaluation findings to appropriate stakeholders and recommends changes to enhance the program, as appropriate.
• Ensures that program activities operate within the policies and procedures of the organization and activities comply with all relevant legislation/regulatory requirements.
• Identifies, solicits, and cultivates community partnerships and collaborations to assist in the development and growth of the program. Develops the metrics to identify and measure the success of the program. Responsible for measurements of grant success and related evaluation.
• Identifies and evaluates potential future funding sources, and contributes to the submission of grants and contracts supporting the program, including the annual submission and writing of all content areas and budgetary sections of grant applications.
• Develops the administrative infrastructure of the program. Manages human resource and administrative functions of the program, including staffing and hiring, supervision, performance development, counseling and discipline, if warranted. Oversees and manages information systems, facilities, and space needs.
• Investigate, identifies, implements, and oversees the maintenance of systems to gather, track, and report information to support the initiatives of the program. Tracks all program activities and regularly informs leadership of progress on each initiative. Recommends structural or programmatic adjustments, changes or additions based on full knowledge of missions, goals, and objectives.
• Initiates, designs, and manages the compilation of program communications; identifying outreach potential, and promoting philanthropic and collaborative support of the program. Contributes to the development and assists in the management of content on the program's website and monitors all changes and additions to the editorial content.
• Performs other duties as assigned.

Required Education and Experience:

Bachelor's degree in a related field. Six years of related experience or an equivalent combination of education and experience.