Study Start Up Operations Manager - Full Time - Wolf River - Registered Nurse (RN)/ Licensed Practical Nurse (LPN) Experience Required
Core
Strategic oversight and operational management of clinical trial study start-up activities, ensuring efficient activation and compliance.
Role type
Manager, Study Start-Up Operations
Builds
Clinical trial activation pipelines for oncology research programs
Domain
Healthcare / Clinical Research / Oncology
Deliverable
client delivery
Required skills
Clinical research experience, FDA regulations knowledge, ICH-GCP guidelines expertise, feasibility assessment, sponsor communication, study activation workflows, project management, organizational skills, analytical skills, problem-solving
Preferred skills
CTMS experience
Technologies
Microsoft Office (Excel, Word, Outlook, Adobe Acrobat), CTMS
Responsibilities
Supervise Study Start-Up Specialists and research start-up personnel; Develop departmental workflows, SOPs, and best practices for study activation; Serve as escalation point for sponsors, CROs, and investigators; Collaborate with Research Leadership on goals and operational priorities; Oversee study start-up activities from feasibility through site activation; Review and assign feasibility requests; Coordinate Research Steering Committee and Disease Research Group review processes; Monitor study activation timelines and address barriers; Oversee Site Qualification, Evaluation, and Initiation Visits; Ensure smooth transition of activated studies to Clinical teams; Maintain oversight of sponsor communications; Monitor study start-up metrics; Collaborate with contracts, regulatory, and clinical teams.
Seniority
Manager, supervisory level
