Clinical Program Manager

Ensures compliance with all federal regulations surrounding the conduct of clinical and translational research including fiscal mattersResponsible for the development and implementation of SOPS for the program including financial matters and issues that are followed by all stakeholders Assist in reviewing, monitoring, and reporting on all studies conducted by the Beacon of HOPE initiative. Ensure that each staff member's ability is assessed regularly Provide qualified competent staff by tracking projected staffing needs against qualifications competencies of current staff to identify any deficiencies, rectify the deficiencies to improve staffing levels.

The Clinical Program Manager (CPM) serves an important role within the company and is the person who leads the delivery of our studies. The CPM serves as the primary liaison between Meharry Medical College Center of Excellence for Clinical and Translational Research teams and the customer and serves as that accountable point for delivery and quality of projects, while maintaining financial control. The CPM will manage cross-functional teams across the organization and study partners from study start-up through close-out activities. The CPM is responsible for the management of complex, multi-center, clinical studies, including FDA-regulated clinical trials, and ensures that all clinical study management and project deliverables are completed to the sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with Standard Operating Procedures (SOPs), policies and practices.

Essential Functions (Principal Duties and Job Responsibilities):

• Assist in overseeing the day-to-day operations of the Beacon of HOPE initiative including ongoing clinical trials
• Responsible for the development of program goals and objectives
• Participate in periodic management meetings to keep the Executive Director informed of problems and concernsAssist in the development of cost reduction for projects and targets in collaboration with the Executive Director Compiles customized reports on research activity as needed.
• Assists in preparation of the annual operating budgets
• Ensures compliance with all federal regulations surrounding the conduct of clinical and translational research including fiscal mattersResponsible for the development and implementation of SOPS for the program including financial matters and issues that are followed by all stakeholders Assist in reviewing, monitoring, and reporting on all studies conducted by the Beacon of HOPE initiative.
• Trains staff in good clinical practices (GCP)Aligns staffing priorities and develops measures for staff productivity.
• Assist the Executive Director in defining the qualifications and performance expectations for all staff positions through the Performance Development system, including department specific job descriptions, measurable performance standards.
• Along with the Executive Director, create an environment that encourages and supports self-development and learning for all staff through regular feedback. Ensure that each staff member's ability is assessed regularly Provide qualified competent staff by tracking projected staffing needs against qualifications competencies of current staff to identify any deficiencies, rectify the deficiencies to improve staffing levels.
• Recommends, evaluates and interprets personnel actions and policies.
• Counsel employees about disciplinary actions taken in response to violations of institutional policies, including federal policies, or contractual provisions, and discuss such violations with the Executive Director.
• Assist the staff in the conduct of clinical research trials including screening, recruitment and entering data.
• Other duties as assigned

Knowledge, Skills and Abilities Required:

• Knowledge of clinical research principles, Good Clinical Practice (GCP), and human subject protection regulations. Knowledge of FDA regulations, ICH guidelines, HIPAA requirements, and applicable federal, state, and institutional policies. Knowledge of clinical trial operations, including study start-up, participant recruitment, enrollment, retention, and closeout activities. Knowledge of Institutional Review Board (IRB) requirements and regulatory submission processes.
• Knowledge of research budgeting, financial management, and contract compliance.
• Strong leadership, personnel management, and team-building skills. Excellent project management and organizational skills. Ability to manage multiple clinical trials and competing priorities simultaneously. Strong written and verbal communication skills. Skill in developing policies, procedures, and standard operating procedures (SOPs). Proficiency with Microsoft Office Suite, including Excel, Word, PowerPoint, and Teams.
• Ability to lead and supervise multidisciplinary research teams. Ability to ensure compliance with regulatory, sponsor, and institutional requirements. Ability to establish and maintain effective relationships with investigators, sponsors, CROs, regulatory agencies, and institutional leadership. Ability to manage budgets and allocate resources effectively.
• Ability to work independently while managing multiple projects and deadlines.
• Ability to obtain and maintain all institutional, sponsor, and regulatory certifications necessary to support assigned clinical research studies and program operations.