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University of Oklahoma · 4 weeks ago

*Clinical Trials Manager - Regulatory Affairs

Oklahoma City, OK

Full-time

Onsite

Mid, Senior Level

4+ years exp

University of Oklahoma is home to the OU Health Stephenson Cancer Center, a prestigious National Cancer Institute-Designated Cancer Center. The Clinical Trials Manager – Regulatory Affairs is responsible for overseeing the clinical trials program, managing the regulatory team, ensuring compliance with regulatory requirements, and enhancing operational practices.

EducationHigher EducationUniversities

Responsibilities

Provides direct administrative and fiscal management for regulatory affairs of the program(s) and related grants

Manages the day-to-day business operations of the program

Responsible for overseeing, planning, and monitoring of strategic plans

Manages and implements new workflows and processes to help improve collaboration within all CTO teams

Responsible for fiscal oversight and management to include decisions regarding appropriate rates within University approved salary ranges for new hires, appropriate increases and promotions for existing staff, and approval of purchases for the Regulatory team such as supplies and equipment

Responsible for financial planning of the program(s) and monitoring progress

Develops and manages the Regulatory team’s budget

Ensures the fiscal viability of programs and advises college/department leadership on long-range financial planning and development of new initiatives

Ensures staff correctly identifies clinical trial types and the initial assessment of appropriate start up activity to verify completeness, that all applicable trial documents are accurately reflected for the trial, and the consent forms for each study are approved, inclusive of federal, state and institutional required language

Responsible for conducting ongoing assessments of outreach and timelines to determine needed services, funds, and staffing

Ensures clinic staff and other departments are made aware of new regulatory processes, workflows and standards

Networking with other cancer institutions and applicable research partners to learn and share best practices and improve internal processes

Builds and maintains community relationships with outside physicians, other health care organizations, and serves as referral resource for non-CTO staff and investigators

Ensures completion of all aspects of study start up, continuing review, and study close-out are complete from a regulatory perspective

Manages clinical trials data and performs data analysis

Establishes and maintains reporting metrics and operational functions to leadership to help meet the institutional mission and objectives

Attends and presents clinical trial and regulatory information at various meetings

Supervises assigned staff to include hiring, training, scheduling workloads, evaluating, and terminating employees

Ensures all employees adhere to institutional policies and procedures while ensuring federal regulations are met

Performs various duties as needed to successfully fulfill the function of the position

Qualification

Clinical trials managementRegulatory affairsData managementBudget managementHealth administrationPersonnel supervisionNetworkingCommunication skills

Required

Bachelor's Degree in health-related field to include Health Administration, Public Health, Nursing, or closely related field

48 months experience in clinical trials research coordination and/or administration, professional level data management and analysis, or other closely related professional level role