Post Award Finance Oncology Manager - Atrium Health - FT

American Addiction Centers • Charlotte, NC

50d • Hybrid

About The Position

The Post Award Finance Oncology Manager will manage multiple projects and ongoing work activities, ensuring work plans and deliverables are met. This role is responsible for the follow-up on trial subject safety matters and regulatory management of trials. The manager will allocate resources appropriately, oversee the recruitment, interviewing, onboarding, training, mentoring, performance management, and collaboration of teammates. They will also communicate with teammates, manage remote training and dialogue, and assist with enterprise-wide training related to specific trials, projects, or processes. Key responsibilities include coordinating and managing study subjects, educating them and their families about research studies, treatments, side effects, and follow-up; ensuring subject eligibility; and ensuring timely and accurate data collection and reporting. The manager will also maintain appropriate documentation, assist with study start-up, contracting, and regulatory processes, develop project budgets, track financial performance, manage time and effort reports, resolve subject billing issues, and ensure fiscal stewardship. Compliance with Good Clinical Practice (GCP), ICH, OHRP, FDA, corporate and departmental SOPs, and applicable state/federal law is critical. The role involves managing subject safety through oversight of adverse event and safety reporting, and internal communications for appropriate clinical follow-up. The manager will prepare for and respond to audit findings, coordinate corrective action plans (CAPA), and communicate project status, issues, and timelines to investigators, peers, and leadership. Participation in Institute-wide meetings and assisting the leadership team in cost reduction and process improvement efforts are also expected. A strong understanding of scientific methods, biological principles, medical terminology, GCP, ICH Guidelines, and regulatory requirements (FDA, IRB, OHRP) is necessary.

Requirements

• Bachelor's Degree required, health/science preferred.
• Minimum of 3 years clinical trials experience with a pharmaceutical company, Contract Research Organization (CRO), research center or equivalent required.
• Oncology experience strongly preferred.
• Knowledge of Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines, as well as applicable rules/regulations pertaining to research.
• Knowledge of regulatory requirements of the Food and Drug Administration (FDA), Institutional Review Boards (IRB), and Human Subjects Protections (OHRP) pertaining to clinical research.
• Must speak and read/write clearly in English.

Nice To Haves

• Certification in clinical research (SoCRA CCRP, ACRP, RAPS, or similar) preferred.

Responsibilities

• Manages multiple projects and ongoing work activities ensuring work plans and deliverables are met.
• Ensures follow-up on trial subject safety matters as well as regulatory management of trials in their portfolio.
• Allocates resources appropriately to meet departmental needs.
• Recruits; interviews; onboards; trains; mentors and coaches; manages performance; works across teams to collaborate on recruitment process.
• Communicates with teammates and manages remote training/dialogue.
• Assists with training teammates across enterprise as it relates to a specific trial, project, or process.
• Coordinates and manages study subjects; educates subjects and families about research studies, treatments, side effects, and follow-up; ensures subject eligibility for participation in clinical trial, ensures timely and accurate data collection and reporting, maintains appropriate documentation on study subjects, as required by the sponsor and standard practices.
• Assists teammates with start-up, contracting and regulatory process for sponsored projects, develops project-related budgets, tracks project financial performance, time and effort reports, resolution of subject billing issues, and fiscal stewardship of departmental resources.
• Ensures all aspects of the team's work is accomplished in compliance with accepted Good Clinical Practice (GCP), ICH, OHRP, FDA, corporate and departmental SOPs, and applicable state/federal law.
• Manages safety of research subjects by oversight of adverse event and safety reporting, as well as internal communications to ensure appropriate clinical follow-up.
• Prepares and responds to audit findings and coordinates corrective action plans (CAPA).
• Communicates on-going project status, potential issues, and timelines to investigators, peers and leadership as appropriate.
• Participates in Institute-wide meetings pertaining to area of responsibility (e.g. Section Meetings, Protocol Review, Tumor Board, clinic-based, etc.).
• Assists leadership team in seeking ways to reduce costs and improve processes and efficiency.

Benefits

• Comprehensive suite of Total Rewards
• Benefits and well-being programs
• Competitive compensation
• Generous retirement offerings
• Programs that invest in your career development
• 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
• Educational Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1-10 employees