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 concerns< >Assist 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 matters< >Responsible 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.
Knowledge, Skills, Abilities Preferred:
- Project Management Certification (e.g. PMP, ACRP, SOCRA or equivalent professional certification preferred) Knowledge of Phase I-IV pharmaceutical and biotechnology clinical trials. Knowledge of NIH, PCORI, CDC, HRSA, and other federally funded research programs. Knowledge of clinical research billing compliance.
- Knowledge of grant administration and post-award management.
- Experience negotiating study budgets and clinical trial agreements. Experience implementing Clinical Trial Management Systems (CTMS), electronic regulatory systems, and research technologies.
- Experience mentoring research coordinators, nurses, and other clinical research personnel.
- Ability to analyze performance metrics and implement data-driven improvements. Ability to represent the organization in professional, regulatory, and sponsor interactions.
Education and Experience Required:
- Bachelor's degree or its international equivalent in health/life sciences or related field.
- Organized, proficient at multi-tasking with exceptional attention to detail.
- Ability to lead, motivate and coordinate teams, effectively delegate tasks, and is comfortable collaborating and communicating with a variety of colleagues and clients.
- Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, Smartsheet’s, etc.
- Demonstrates strong interpersonal, communication, and stakeholder management skills. Knowledge of the key principles of cross-functional project management (Time, Quality, Cost). Ability to establish and maintain systems and processes necessary to control and report trial status and activities.
- Full understanding of ICH GCP, FDA regulations, and applicable U.S. clinical trial regulations, including 21 CFR requirements.
- Ability to ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget. Minimum of two (2) years of supervisory, management, or program leadership experience. Experience managing multiple clinical trials simultaneously. Experience with regulatory compliance, IRB submissions, and study oversight. Experience developing and implementing research policies and procedures.
- Experience managing research staff, performance evaluations, and employee development. Experience collaborating with investigators, sponsors, CROs, and institutional stakeholders. Experience with clinical trial budgets, invoicing, and financial oversight.
Education and Experience Preferred:
- Five (5) or more years of progressive clinical research experience, including at least two (2) years of clinical project management experience within a CRO, sponsor, biotech, pharmaceutical, academic medical center, or related environment. Experience supporting FDA-regulated clinical trials conducted within the United States.
- Certification as a Clinical Research Professional through Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP).
- Project Management Professional (PMP) certification (PMP, ACRP, SCCRA or equivalent professional certification preferred).
- Three (3) or more years of program management experience within an academic medical center, research institute, or healthcare system.
- Experience managing large, multi-site, federally funded, or industry-sponsored clinical research programs.
- Experience supporting NIH, PCORI, CDC, HRSA, pharmaceutical, or biotechnology-sponsored studies.
- Experience with research pharmacy, laboratory operations, and investigational product management.
Licensure, Certification or Registration Required:
- Current certification in Human Subjects Protection and Good Clinical Practice (GCP), or the ability to obtain certification within 30 days of hire. Completion of required institutional compliance training (e.g., HIPAA, OSHA Bloodborne Pathogens, Information Security, and Conflict of Interest) within the prescribed timeframe. Valid driver's license and ability to travel to research sites, if required by the position.
Licensure, Certification or Registration Preferred:
- Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SOCRA). Certified Clinical Research Coordinator (CCRC) or Certified Principal Investigator (CPI) through the Association of Clinical Research Professionals (ACRP).
