Manager, Study Operations – Operations Readiness Team

This is a fully remote position, open to applicants in Texas.

📋 Description

• Develop, lead, and continually refine a deployable team of operational readiness specialists across CRC, DC, Infusion Nursing, Scheduling, Clinical Administrative Assistant, Patient Navigation, IDS, and PK.

• Allocate and oversee team deployments based on site requirements, launch schedules, and risk indicators.

• Create training programs, checklists, and standard operating procedures for onboarding new sites and addressing challenges at underperforming sites.

• Take ownership of operational readiness plans for new site launches, encompassing staffing ramp-up, workflow configuration, systems onboarding, and role-specific training.

• Collaborate with site leadership to confirm staffing models, spatial arrangements, and departmental workflows prior to go-live.

• Identify and report operational, staffing, quality, and safety risks to the VP of Regional Operations.

• Assess site performance using staffing ratios, data timeliness, quality and safety metrics, and patient volume trends.

• Deploy the readiness team to stabilize sites facing leadership gaps, staffing shortages, quality or safety concerns, or rapid increases in volume.

• Analyze root causes of site underperformance and execute corrective action plans.

• Decide when sites can shift away from direct readiness team support.

• Act as a liaison for Principal Investigators during site launches and stabilization phases.

• Ensure readiness team training aligns with enterprise training standards and curricula.

• Coordinate readiness deployments with milestones related to new site integration and acquisitions.

• Collaborate with Quality Assurance and Compliance leadership to reduce site-level risks and integrate standards into training, checklists, and stabilization playbooks.

⛳️ Requirements

• Bachelor’s degree in nursing, health administration, or a related field.

• CITI GCP training.

• Understanding of GCP and relevant federal clinical research regulations in the United States.

• Over 5 years of experience in clinical research operations, healthcare operations, or site management, including direct personnel leadership.

• Proficient with Microsoft Office applications and clinical documentation systems.

• Willingness to travel approximately 50%, including extended stays to facilitate new site launches and stabilizations.

• Master’s degree in health administration, nursing, or another relevant field is preferred.

• Experience in leading or establishing teams or departments in an oncology clinical research environment, including new site launches or turnarounds is preferred.

• Specialty certification in research or a related field is preferred.

• Proven engagement in professional practice and industry advancement is preferred.

• BLS certification is preferred.

🏝️ Benefits

• 401(k) retirement savings plan with employer match.

• Eligibility for an annual performance bonus, contingent on role and company performance.

• Generous paid time off and paid holidays.

• Comprehensive medical, dental, and vision insurance, along with optional coverage options.

• Company-sponsored life and disability insurance.

• Employee Assistance Program (EAP) offering confidential, no-cost support for you and your family from day one.

• Flexible FSA and HSA plans.

• Supportive work environment that prioritizes balance, wellbeing, and flexibility.

• Opportunities for continuous learning and professional development.

• A collaborative, creative, inclusive, and innovative workplace.