Manager, Clinical Research Operations
- Location
- AUSTIN, TX
- Work mode
- On-site
- Employment type
- Full-time
About the job
Job Posting Title: Manager, Clinical Research Financial Operations ---- Hiring Department: Dell Medical School ---- Position Open To: All Applicants ---- Weekly Scheduled Hours: 40 ---- FLSA Status: Exempt from FLSA ---- Earliest Start Date: Oct 05, 2026 ---- Position Duration: Expected to Continue Until Sep 30, 2029 ---- Location: AUSTIN, TX ---- Job Details: General Notes Dell Medical School is seeking a Manager, Clinical Research Financial Operations.
This is a 3-year grant-funded position with an end date of September 30, 2029, renewable based on availability of funding, work performance, and progress toward goals.
Purpose The Manager, Clinical Research Financial Operations manages day‑to‑day centralized clinical research operations within the Clinical Trials Office (CTO) and supports consistent execution of clinical trial workflows across participating departments. Reporting to the Senior Manager, Clinical Research Operations, this role oversees research coordinator pools and operational staff responsible for study start‑up execution, regulatory submissions, trial coordination activities, and participant recruitment support.
The Manager implements standardized operational procedures, ensures compliance with federal regulations and institutional policies, and supports efficient activation and execution of clinical trials. This role collaborates closely with investigators, departmental research units, regulatory offices, research finance, and clinical operations to ensure high‑quality study conduct and operational readiness across the institutional research portfolio.
ESSENTIAL JOB FUNCTIONS: Operational Oversight & Process Implementation · Manages day‑to‑day operations of centralized clinical research services including study start‑up, trial coordination, regulatory workflows, and recruitment support. · Implements operational procedures, service workflows, and performance expectations established by the CTO. · Supports the development and maintenance of standard operating procedures (SOPs), job aids, and guidelines for clinical research operations. · Monitors key operational metrics such as study activation timelines, coordinator workload, regulatory submission timeliness, and enrollment progress. · Identifies process gaps and recommends operational improvements to enhance efficiency and compliance. Research Coordinator Pool Management & Workforce Support · Supervises centralized research coordinators and operational staff, including hiring, onboarding, training, performance evaluation, and day‑to‑day oversight. · Assigns coordinator resources to studies based on protocol complexity, enrollment expectations, and departmental needs. · Ensures consistent application of operational standards, documentation practices, and participant management workflows. · Supports workforce development, competency assessment, and professional growth for coordinators and operational staff. · Contributes to workforce planning and resource‑allocation strategies to meet institutional research demands. Clinical Trial Start-Up & Study Activation Coordination · Oversees operational components of feasibility review, study intake, and activation readiness activities. · Coordinates with contracting, coverage analysis, budgeting, IRB, regulatory, Epic Research, and CTMS teams to ensure timely activation. · Tracks start‑up progress, monitors milestones, and identifies operational barriers affecting study initiation. · Implements activation workflows, communicates expectations to study teams, and supports continuous improvement efforts. Regulatory Support & Compliance Monitoring · Oversees regulatory submission activities including initial submissions, amendments, continuing reviews, and safety reporting. · Ensures compliance with institutional policies, FDA regulations, ICH‑GCP guidance, and federal research requirements. · Supports operational readiness for audits, inspections, and sponsor monitoring visits. · Assists with oversight of investigator‑initiated studies, including documentation, compliance tracking, and submission coordination. Recruitment Support & Research Systems Integration · Supports centralized recruitment strategies and participant engagement initiatives. · Coordinates with research technology platforms including Epic Research, CTMS, and eRegulatory systems to support operational workflows. · Ensures research systems are used consistently to document study activity, support regulatory compliance, and maintain reporting accuracy.
Marginal or Periodic Functions: · Participates in CTMS and EHR upgrade testing, workflow redesign, and go‑live support. · Represents clinical research operations on institutional committees and cross‑functional workgroups. · Performs operational analyses to investigate defects or barriers affecting study performance. · Assists with onboarding new departments into centralized research operational workflows and systems. · Adheres to institutional internal controls and reporting structures. · Performs other related duties as assigned.
KNOWLEDGE/SKILLS/ABILITIES Integrity and Trust
• Handles confidential participant, institutional, and regulatory information responsibly.
- Handles confidential participant, institutional, and regulatory information responsibly.
- Escalates potential noncompliance promptly and documents appropriate operational decisions.
- Maintains transparency while safeguarding PHI and sensitive research information.
• Implements standardized workflows to support efficient clinical trial execution.
- Implements standardized workflows to support efficient clinical trial execution.
- Supports process improvements and updates SOPs, job aids, and training materials.
- Works with Research IT and operational teams to optimize CTMS, EHR research modules, and eRegulatory workflows.
• Monitors operational performance and ensures service levels are met.
- Monitors operational performance and ensures service levels are met.
- Tracks workload distribution across coordinator pools and operational teams.
- Uses performance metrics to identify improvement needs and coach staff.
• Investigates operational issues using protocol documentation, regulatory requirements, and workflow analysis.
- Investigates operational issues using protocol documentation, regulatory requirements, and workflow analysis.
- Implements sustainable solutions through workflow modifications and training.
- Collaborates across departments to resolve study‑level obstacles.
• Supports investigators and study teams with clear processes and predictable timelines.
- Supports investigators and study teams with clear processes and predictable timelines.
- Balances operational efficiency with regulatory and institutional requirements.
- Builds strong working relationships with clinical departments, regulatory offices, finance, and research teams.
• Communicates clearly with investigators, coordinators, staff, sponsors, and institutional partners.
- Communicates clearly with investigators, coordinators, staff, sponsors, and institutional partners.
- Translates regulations and institutional policies into actionable operational guidance.
- Presents operational updates and findings to leadership as needed.
- Maintains effectiveness in dynamic, evolving research environments.
- Provides guidance on complex studies and operational decisions with incomplete information.
- Helps maintain operational continuity during system changes or workflow transitions.
EDUCATION & EXPERIENCE Minimum Qualifications:
- Bachelor’s degree in Healthcare Administration, Public Health, Life Sciences, Nursing/Allied Health, Business Administration, or related field.
- 5 years of experience in clinical research operations, clinical coordination, start‑up, regulatory management, or related clinical research activities.
- Experience supporting study lifecycle activities including feasibility review, activation, study conduct, and close‑out.
- Experience working with CTMS, eRegulatory systems, and/or EHR research modules such as Epic Research.
Preferred Qualifications:
- Master’s degree in Healthcare Administration, Public Health, Business Administration, or related field.
- Supervisory experience or team-lead experience overseeing clinical research staff or operational workflows.
- 7 years of experience in academic medical center or large health system research operations.
- Experience scaling or supporting centralized coordinator pools, start‑up units, recruitment services, or regulatory service lines.
- Experience supporting FDA inspections, sponsor audits, or institutional compliance reviews.
LICENSES, REGISTRATIONS OR CERTIFICATIONS Required:
- None
Preferred:
- ACRP or SOCRA certification (CCRP, CCRC, or equivalent)
- CIP (Certified IRB Professional)
- CRA (Certified Research Administrator)
- Certification or proficiency with Epic Research, CTMS platforms (e.g., OnCore), or equivalent research systems
- GCP or FDA‑regulated research training/certification
Salary Range $88,516 + depending on qualifications
SUPERVISION *Required for Supervisor and above job descriptions Direct supervision: Clinical Research Operations Analysts (I-III)
BUDGET RESPONSIBILITY *Required for Associate Director and above job descriptions
- N/A
DECISION-MAKING RESPONSIBILITY *Required for Supervisor and above job descriptions Autonomous Decisions
• Prioritizes operational work queues including start‑up tasks, regulatory submissions, and coordinator assignments.
- Prioritizes operational work queues including start‑up tasks, regulatory submissions, and coordinator assignments.
- Allocates coordinator resources based on study complexity and operational need.
- Implements workflow updates, training, and SOP changes within established governance.
- Interprets institutional policies and regulatory guidance for routine operational scenarios.
- Resolves day‑to‑day operational issues affecting study conduct.
- Initiates formal regulatory or compliance escalations.
- Approves significant operational changes affecting enterprise research systems.
- Recommends major changes to institutional coordinator models or operational procedures.
- Approves major resource reallocations, expansion requests, or new service line development.
WORKING ENVIRONMENT/EQUIPMENT · Standard office environment · Repetitive use of keyboard and computer · May have occasional exposure to clinical environments or occupational hazards (e.g., PHI, radiation, hazardous medications, or patient interactions)
Required Materials
- Resume/CV
- 3 work references with their contact information; at least one reference should be from a supervisor
- Letter of interest
Important for applicants who are NOT current university employees or contingent workers: You will be prompted to submit your resume the first time you apply, then you will be provided an option to upload a new Resume for subsequent applications. Any additional Required Materials (letter of interest, references, etc.) will be uploaded in the Application Questions section; you will be able to multi-select additional files. Before submitting your online job application, ensure that ALL Required Materials have been uploaded. Once your job application has been submitted, you cannot make changes.
Important for Current university employees and contingent workers: As a current university employee or contingent worker, you MUST apply within Workday by searching for Find UT Jobs. If you are a current University employee, log-in to Workday, navigate to your Worker Profile, click the Career link in the left hand navigation menu and then update the sections in your Professional Profile before you apply. This information will be pulled in to your application. The application is one page and you will be prompted to upload your resume. In addition, you must respond to the application questions presented to upload any additional Required Materials (letter of interest, references, etc.) that were noted above. ---- Employment Eligibility: Regular staff who have been employed in their current position for the last six continuous months are eligible for openings being recruited for through University-Wide or Open Recruiting, to include both promotional opportunities and lateral transfers. Staff who are promotion/transfer eligible may apply for positions without supervisor approval. ---- Retirement Plan Eligibility: The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the po
From The University of Texas at Austin's careers page (Workday), checked 30 Oct 2026.
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Posted 2 Oct 2026 · checked 30 Oct 2026 · Report this job