Study Start Up Operations Manager - Full Time - Wolf River

West Cancer Center•Germantown, TN

1d•Onsite

About The Position

At West Cancer Center, we are committed to advancing innovative cancer research while delivering compassionate, patient-centered care. 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. 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 role supervises the Study Start-Up Specialist 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, contracts/budgets, data services, and clinical research teams. The Manager ensures efficient activation of clinical trials while maintaining compliance with FDA regulations, GCP guidelines, sponsor requirements, and organizational policies. This position requires a licensed nurse with clinical research experience, leadership ability, and expertise in research processes.

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
Excellent organizational, analytical, and problem-solving skills
Ability to manage multiple projects and priorities in a fast-paced environment
Strong verbal and written communication skills
Proficient in Microsoft Office applications including Excel, Word, Outlook, and Adobe Acrobat
Current RN/LPN license required

Nice To Haves

Experience with CTMS preferred

Responsibilities

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
Develops departmental workflows, SOPs, and best practices related to study activation and feasibility processes
Serves as escalation point for sponsors, CROs, investigators, and internal departments regarding study start-up issues or delays
Collaborates with Research Leadership to establish departmental goals, activation metrics, and operational priorities
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
Maintains oversight of sponsor communications and manages sponsor expectations throughout the start-up process
Oversees maintenance of staff training records, GCP documentation, and protocol-specific training documentation
Collaborates with contracts/budget and regulatory teams to support timely study activation
Monitors study start-up metrics including activation timelines, pending studies, feasibility outcomes, and sponsor responsiveness
Works collaboratively with investigators, research nursing, regulatory, data management, pharmacy, laboratory, finance, and sponsor representatives
Interfaces with pharmaceutical companies, CROs, and external research partners
Participates in department meetings, sponsor meetings, and organizational initiatives
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