Manager Clinical Research - Office of Clinical Research

WHY UT SOUTHWESTERN?
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career! 

JOB SUMMARY
Office of Clinical Research (OCR) is seeking an experienced, highly organized Multi-Site Clinical Trial Manager (CTM) to oversee the execution of our complex, multi-center clinical trials. In this role, you will serve as the operational backbone of our studies, managing trial progression across multiple clinical research sites from study startup through study close out. The ideal candidate brings 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 skills and trouble-shooting skills are required.

 

BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include\:

• 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
• Learn more about these and other UTSW employee benefits!

EXPERIENCE AND EDUCATION

Required

• Education
  Master's Degree In science, social science, healthcare administration, or a related field 
   

• Experience
  5 years Of experience managing clinical trials and 
  Equivalent combination of education and relevant experience may be considered in lieu of Master's degree. 
   

JOB DUTIES

• Oversees the organizational and operational activities of the Disease-Oriented Teams (DOTs). Develops performance standards and expectation for DOT managers and teams, and periodically assess 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. Fulfill 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 with 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 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 implement training and education for managers and staff performing these functions.
• Oversees and optimizes the process for collecting, storing and tracking clinical biospecimens, working closing with institutional resources. Ensures storage space is available and managed appropriately.
• Performs other duties as assigned.

SECURITY AND EEO STATEMENT

Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

EEO
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.
 

WHY UT SOUTHWESTERN?
With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career! 

JOB SUMMARY
Office of Clinical Research (OCR) is seeking an experienced, highly organized Multi-Site Clinical Trial Manager (CTM) to oversee the execution of our complex, multi-center clinical trials. In this role, you will serve as the operational backbone of our studies, managing trial progression across multiple clinical research sites from study startup through study close out. The ideal candidate brings 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 skills and trouble-shooting skills are required.

 

BENEFITS
UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include\:

• 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
• Learn more about these and other UTSW employee benefits!

EXPERIENCE AND EDUCATION

Required

• Education
  Master's Degree In science, social science, healthcare administration, or a related field 
   

• Experience
  5 years Of experience managing clinical trials and 
  Equivalent combination of education and relevant experience may be considered in lieu of Master's degree. 
   

JOB DUTIES

• Oversees the organizational and operational activities of the Disease-Oriented Teams (DOTs). Develops performance standards and expectation for DOT managers and teams, and periodically assess 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. Fulfill 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 with 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 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 implement training and education for managers and staff performing these functions.
• Oversees and optimizes the process for collecting, storing and tracking clinical biospecimens, working closing with institutional resources. Ensures storage space is available and managed appropriately.
• Performs other duties as assigned.

SECURITY AND EEO STATEMENT

Security
This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.

EEO
UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status.