Note: The job is a remote job and is open to candidates in USA. Meharry Medical College is seeking a Clinical Program Manager to lead the delivery and quality of complex clinical research studies. The role manages cross-functional teams and study partners from start-up through closeout, oversees clinical trials and program operations, and ensures regulatory compliance, financial control, and timely delivery within budget.
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
Skills
- 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
- 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
- Current certification in Human Subjects Protection and Good Clinical Practice (GCP), or the ability to obtain certification within 30 days of hire
- 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
- 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
- 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)
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