Clinical Trial Oversight Project Manager, National Center for Clinical Trials (NCCT

JOB SUMMARY

The National Center for Clinical Trials (NCCT) is designed to serve as an innovative platform to revolutionize and catalyze the conduct of clinical trials−greatly accelerating the translation of scientific findings into improvements in the prevention, diagnosis, and treatment of disease for our communities and patients. The NCCT will offer core services for patient recruitment and enrollment, trial administration and follow-up, and to gather real world data and evidence.

This position will be part of a team that will report to leadership in the NCCT and will manage the clinical trial feasibility review process and the oversight of trial performance.

EDUCATION/EXPERIENCE

• Master’s degree related to project management and evaluation, such as Epidemiology, Public Health, Psychology, or Sociology and four years of relevant administrative and medical experience in research projects or other health-related activities; or, an equivalent combination of education and experience.

• Two years’ experience in a supervisory capacity.

ESSENTIAL FUNCTIONS

The Clinical Trial Oversight Project Manager (CTOPM) assesses overall feasibility of clinical trials as they are presented to NCCT and works with other functional areas to gather information and render a decision as to whether trials will move forward in the negotiation process. In addition, the CTOPM works with study teams to facilitate trial set up and once a trial is activated, the CTOPM monitors and manages the overall progress of the trial through closeout.

• Works with informatics team to analyze availability of patient cohorts and potential subject accrual challenges given competing trials.

• Reviews potential trial opportunities and distributes information about the trials to functional areas and leaders to analyze potential participation.

• Works with service line and site leaders to assess scientific merit of trials, feasibility, site readiness and resources.

• Evaluates all potential sites for activation working with site teams, ancillary services team, study teams and site resource managers. Factors to be taken into account for site assessment include staffing, ancillary services, resources/equipment, geographical location with respect to eligible patients, interested PIs at potential sites and sponsor interest in number of sites.

• Works with Recruitment, Call Center and Data Coordinating Center to develop patient matching, recruitment and study conduct plans.

• Reviews ongoing and upcoming trials and works with leadership to prioritize competing trials.

• Works with IT team to assess IT needs for trials. Facilitates and attends site initiation visits.

• Responsible for outreach to applicable physicians, care teams, etc to gain valuable information.

• Maintain working knowledge of clinical trials within research portfolio. Conducts preliminary review of central needs for trials.

• Connects study staff members with training resources as necessary for compliance with policies.

• Monitors progress of the clinical trial until completion ensuring accrual, study activities and quality measures are met.

• Liaises with regulatory to monitor amendments, personnel changes, etc. Liaises with sponsor, investigator(s) and site staff throughout trial.

• Monitors resource demands throughout trial.

• Supports the deployment of coordinators and Advanced Care Providers in conjunction with Site Resource Managers to sites as needed for study conduct.

• Performs other related duties incidental to the work described herein.

SKILLS/QUALIFICATIONS

• Must have 4+ years managing projects and/or processes.

• Must have 2 years in a supervisory capacity.

• Must have 5+ years of experience working with clinical trials.

• Working knowledge of clinical trial management systems and electronic medical records.

• Detailed understanding of clinical trial operations and challenges from the site perspective.

• Experience in leading teams and in decision-making role(s).

• Excellent written and verbal communication skills.

• Excellent organizational skills and attention to detail.

• Demonstrated ability to work independently as well as in a team environment.

• Proficiency with Microsoft Office, Microsoft Excel and Microsoft PowerPoint.

About Us

Wake Forest University School of Medicine (WFUSM) is a U.S. News and World Report top 50 ranked medical school, integrated with a world-class health system, Atrium Health. WFUSM, the academic core of Atrium Health Enterprise, is a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery.

WFUSM, has over $300M in annual, extramural funding that drives a cutting-edge Academic Learning Health System by integrating innovative research with excellent patient care across our enterprise.

Atrium Health is based in Winston-Salem, North Carolina and is part of Advocate Health, which is headquartered in Charlotte, North Carolina, and is the fifth-largest…