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

About the role

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.

Responsibilities

• 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.
• 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.
• Connects study staff members with training resources as necessary for compliance with policies.
• Maintains oversight of clinical trial progress 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.
• Maintains awareness of 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.

Requirements

• 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.
• Five 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.

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.

Skills

• 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.

Benefits

Comprehensive suite of Total Rewards including:

• Paid Time Off programs
• Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
• Flexible Spending Accounts for eligible health care and dependent care expenses
• Family benefits such as adoption assistance and paid parental leave
• Defined contribution retirement plans with employer match and other financial wellness programs
• Education Assistance Program

Pay

$38.20 - $57.30

Schedule

Full-time, Fully Remote