Westcancercenter
Study Start Up Operations Manager - Full Time - Wolf River - Registered Nurse (RN)/ Licensed Practical Nurse (LPN)
Germantown, TN · Full-time
Sponsorship not specifiedDetected 28 days ago
GCPExcelPerformance ManagementClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationProblem SolvingMentoringMicrosoft Office
About the role
- Our research teams play a critical role in expanding treatment opportunities and improving outcomes for patients through cutting-edge clinical trials and collaborative research initiatives.
- Position Overview The Manager, Study Start Up Operations is responsible for the strategic oversight, leadership, and operational management of all clinical trial study start-up activities across the research program.
- This position requires a licensed nurse with clinical research experience, leadership ability, and expertise in research processes.
Responsibilities
- Develops departmental workflows, SOPs, and best practices related to study activation and feasibility processes
- Collaborates with Research Leadership to establish departmental goals, activation metrics, and operational priorities
- Maintains oversight of sponsor communications and manages sponsor expectations throughout the start-up process
- Collaborates with contracts/budget and regulatory teams to support timely study activation
- Interfaces with pharmaceutical companies, CROs, and external research partners
- Maintains professionalism, confidentiality, and ethical standards in all interactions
- Supports special projects and strategic initiatives as assigned by Research Leadership
- Performs all other duties as assigned
Requirements
- Minimum of two (2) years of clinical research experience required
- Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial start-up processes
- Experience with feasibility assessments, sponsor communications, and study activation workflows
- Current RN/LPN license required
- Ability to sit, stand, walk, reach, bend, and use hands/wrists for extended periods of time
- Ability to effectively communicate verbally and in writing
- Ability to lift up to 25 pounds
- Occasional travel for investigator meetings, sponsor visits, or conferences may be required
Nice to have
- Experience with CTMS preferred
Benefits
- Comprehensive benefits package.
Company info
- Directly supervises Study Start-Up Specialists and other assigned research start-up personnel
- Provides leadership, mentorship, training, and performance management for study start-up staff
- Serves as escalation point for sponsors, CROs, investigators, and internal departments regarding study start-up issues or delays
- Participates in strategic planning for research growth and study portfolio development
- Oversees all study start-up activities from initial feasibility through site activation and handoff to study conduct teams
- Reviews and assigns feasibility requests and ensures timely completion of sponsor-required questionnaires
- Oversees Confidential Disclosure Agreements (CDAs), protocol review workflows, and study routing processes
- Coordinates Research Steering Committee (RSC) and Disease Research Group (DRG) review processes
- Monitors study activation timelines and proactively addresses barriers to activation
- Oversees Site Qualification Visits (SQVs), Site Evaluation Visits (SEVs), and Site Initiation Visits (SIVs)
- Ensures smooth transition of activated studies to Clinical team
Visa & Work Authorization
- ecialist and Research Specialist positions and serves as the primary operational lead for feasibility, site activation, sponsor communication, start-up timelines, and cross-functional coordination with regulatory, contra
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