Manager, Clinical Research, Office of Clinical Research

UT Southwestern Medical Center • Dallas, TX

2d • Onsite

About The Position

The Office of Clinical Research (OCR) is seeking an experienced, highly organized Multi-Site Clinical Trial Manager (CTM) to oversee the execution of complex, multi-center clinical trials. This role serves as the operational backbone of studies, managing trial progression across multiple clinical research sites from study startup through study close out. The ideal candidate will have a strong background in clinical research, site startup and management, monitoring oversight, and cross-functional leadership, ensuring all milestones are met on time, within budget, and in strict compliance with ICH-GCP guidelines and regulatory requirements. Exceptional people management and trouble-shooting skills are required.

Requirements

• Master's Degree in science, social science, healthcare administration, or a related field
• 5 years of experience managing clinical trials
• Exceptional people management skills
• Exceptional trouble-shooting skills

Nice To Haves

• Equivalent combination of education and relevant experience may be considered in lieu of Master's degree.

Responsibilities

• Oversees the organizational and operational activities of the Disease-Oriented Teams (DOTs).
• Develops performance standards and expectations for DOT managers and teams, and periodically assesses the attainment of these standards.
• Consults with DOT managers and faculty leaders to set performance expectations for research nursing and technical staff managing clinical trials.
• Works with the members of the team to identify, develop, and evaluate key core competencies of clinical research personnel in an effort to tailor training needs.
• Maintains peer-level working relationships with faculty and academic departments across UTSW to oversee the conduct of clinical trials.
• Fulfills duties of DOT managers in their absence.
• Oversees the financial and administrative resources available for the management of clinical trials by DOTs, working closely with leadership, staff, and faculty from various departments within UTSW Medical Center.
• Develops budget, fee, cost recovery, and revenue recommendations for DOT functions.
• Works with DOT Managers to analyze and review study budgets to ensure that all studies are fiscally sound and that all study costs are recovered or minimized.
• Develops and implements best practices for DOT compliance and assurance.
• Develop and manage all DOT internal monitoring programs to ensure compliance with all relevant rules, regulations, and policies.
• Coordinates and oversees the management of affiliate networks conducting clinical trials.
• Analyzes and makes recommendations regarding internal process improvements related to optimal time-to-protocol activation.
• Leads a committee comprised of faculty and staff to annually review and develop new Standard Operating Procedures (SOPs); recommends new and drafts updates to existing SOPs as necessary.
• Directs and oversees the processes for ensuring timely and accurate electronic data capture (EDC) for investigator-initiated clinical trials (IITs).
• Maintains high-level expertise in EDC for IITs, and implements training and education for managers and staff performing these functions.
• Oversees and optimizes the process for collecting, storing, and tracking clinical biospecimens, working closely with institutional resources.
• Ensures storage space is available and managed appropriately.
• Performs other duties as assigned.

Benefits

• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100% coverage for preventive healthcare-no copay
• Paid Time Off, available day one
• Retirement Programs through the Teacher Retirement System of Texas (TRS)
• Paid Parental Leave Benefit
• Wellness programs
• Tuition Reimbursement
• Public Service Loan Forgiveness (PSLF) Qualified Employer

What This Job Offers

• Job Type: Full-time
• Career Level: Manager