Study Start Up Operations Manager - Full Time - Wolf River

Study Start Up Operations Manager - Full Time - Wolf River

Germantown, TN

Manager, Study Start Up Operations

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.

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 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.

Key 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

Qualifications

Education & Experience

Required:

• 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

Preferred:

• Experience with CTMS preferred

Credential/Licensure

Required:

• Current RN/LPN license required

Work Environment & Physical Demands

• Typical clinical and office environment with moderate noise level
• 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

Why West Cancer Center is a Great Place to Work

• Meaningful Impact: Play a direct role in supporting patients through one of the most challenging times of their lives.
• Collaborative Culture: Work alongside a multidisciplinary team of dedicated professionals committed to improving cancer care.
• Professional Development: Benefit from ongoing training, educational resources, and growth opportunities.
• Mission-Driven Environment: Be part of an organization guided by compassion, integrity, and innovation.

No nights, weekends, or holidays. Comprehensive benefits package.

Join Us

If you are a detail-oriented clinical research professional with leadership experience and a passion for advancing oncology research operations, we encourage you to apply for the Manager, Study Start Up Operations position at West Cancer Center.