Manager, Clinical Research Operations

Job Posting Title:
Manager, Clinical Research Operations
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Hiring Department:
Dell Medical School
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Position Open To:
All Applicants
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Weekly Scheduled Hours:
40
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FLSA Status:
Exempt from FLSA
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Earliest Start Date:
Immediately
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Position Duration:
Expected to Continue Until Sep 30, 2029
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Location:
AUSTIN, TX
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Job Details:
General Notes
Dell Medical School is seeking a Manager, Clinical Research 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 Operations manages day‑to‑day centralized clinical research operations 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.
Escalates potential noncompliance promptly and documents appropriate operational decisions.
Maintains transparency while safeguarding PHI and sensitive research information.
Process Management
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.
Managing and Measuring Work
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.
Problem Solving
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.
Customer Focus
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.
Communicating Effectively
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.
Dealing with Ambiguity
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, REGISTRAT

Skills
Clinical Research, GCP, Onboarding, Regulatory Compliance, Documentation