Manager Clinical Research, Internal Medicine

UT Southwestern Medical Center•Dallas, TX

About The Position

The Manager Clinical Research works under limited supervision to implement, oversee, and evaluate programmatic activities associated with clinical trials on the UT Southwestern campus. This role oversees the pulmonary clinical research unit, supervises senior research team members who are direct reports, and provides leadership and oversight for the group. Research areas include pulmonary hypertension, interstitial lung disease, COPD, interventional pulmonology, and lung transplantation, across NIH and industry studies and phase 2–4 pharmaceutical studies. The ideal candidate has significant clinical research experience and strong people-management, regulatory, quality, and operational expertise. The position oversees Disease-Oriented Team operations and performance, clinical research personnel development, trial finances and administration, compliance programs, affiliate networks, SOPs, electronic data capture for investigator-initiated trials, and clinical biospecimen processes. Salary is commensurate with education, skills, and relevant experience.

Requirements

Master's degree in science, social science, healthcare administration, or a related field.
Five years of experience managing clinical trials.
An equivalent combination of education and relevant experience may be considered in lieu of a master's degree.

Responsibilities

Oversee the organizational and operational activities of Disease-Oriented Teams (DOTs), establish performance standards and expectations for DOT managers and teams, and periodically assess whether standards are met.
Consult with DOT managers and faculty leaders to set performance expectations for research nursing and technical staff managing clinical trials.
Work with team members to identify, develop, and evaluate core competencies for clinical research personnel and tailor training needs.
Maintain peer-level working relationships with faculty and academic departments across UT Southwestern to oversee clinical trials, and fulfill DOT manager duties in their absence.
Oversee financial and administrative resources for DOT clinical-trial management in collaboration with institutional leadership, staff, and faculty.
Develop budget, fee, cost-recovery, and revenue recommendations for DOT functions.
Work with DOT managers to analyze study budgets and ensure studies are fiscally sound and costs are recovered or minimized.
Develop and implement DOT compliance and assurance best practices, and manage internal monitoring programs to ensure compliance with applicable rules, regulations, and policies.
Coordinate and oversee affiliate networks conducting clinical trials.
Analyze and recommend internal process improvements to optimize time to protocol activation.
Lead a faculty-and-staff committee that annually reviews and develops Standard Operating Procedures (SOPs), and recommend and draft new or updated SOPs.
Direct and oversee timely, accurate electronic data capture (EDC) for investigator-initiated clinical trials (IITs), maintain expertise in EDC for IITs, and implement training and education for staff performing these functions.
Oversee and optimize the collection, storage, and tracking of clinical biospecimens in coordination with institutional resources, ensuring storage space is available and appropriately managed.
Perform 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 with 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.
On-site childcare.
Paid holidays.