Manager Study Operations

McKesson • Denver, CO

444d

About The Position

The Manager of Study Operations at McKesson is responsible for overseeing research data operations within the Phase I solid tumor Drug Development Unit and the Colorado Blood Cancer Institute research program. This role involves ensuring the accuracy and completeness of clinical trial activities, problem-solving clinical situations, and improving organizational processes related to trial execution. The manager will lead trial management issues, assess data quality, manage budgets, and enhance operational effectiveness while promoting communication and accountability among staff and physicians.

Requirements

• A Bachelor's Degree is required.
• Knowledge of FDA guidelines and GCP.
• Ability to read, understand, and comply with research protocols.
• Experience using clinical trial databases, electronic data capture, MS Access, and MS Excel.
• At least three years of experience in an oncology setting.

Nice To Haves

• At least one year of experience supervising or managing others.
• At least one year of experience in blood cancer/Bone Marrow Transplant (BMT).
• Research Certification (ACRP or CCRP) preferred.

Responsibilities

• Oversee clinical trial-related activities performed by the research staff to ensure completeness and accuracy as well as adherence to federal and state guidelines.
• Problem solve clinical situations along with the research staff and management team as they arise.
• Assess organizational processes associated with trial execution and identify ways to improve and streamline internal procedures.
• Plan, facilitate, and present trial management issues and data status updates at internal and external meetings.
• Provide oversight, leadership, and direction in the management and execution of trials.
• Assess quality of data and performance of clinical trials and develop action plans to address performance gaps.
• Manage, monitor, and operate within allowed budget.
• Review all program billing outcomes and work with billing staff to address issues impacting financial outcomes and patient billing experience.
• Ensure successful implementation of the EMR and optimization of clinic processes related to OncoEMR implementation to support clinic outcomes and patient experience.
• Promote communication and accountability between staff and physicians.
• Monitor billing colleagues and services, provide financial reports, and complete financial analysis to determine areas for improvement in financial outcomes.
• Maintain competency and enhance professional growth and development through continuing education, conferences, and seminars.
• Enhance operational effectiveness, emphasizing cost containment without jeopardizing quality of care.
• Oversee all aspects of patient treatment associated with trial execution, including enrollment, patient consent, lab work, data entry, and drug storage/distribution.
• Keep the executive team informed of issues, progress, and risks related to trial operations and the overall clinic, meeting frequently with all investigators.
• Assist in developing and executing internal and external strategies, responsible for recruitment, hiring, training, development, and termination of colleagues as necessary.

Benefits

• Comprehensive benefits to support physical, mental, and financial well-being.
• Competitive compensation package including base pay, annual bonus, and long-term incentive opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees