Job Description

Job Title: Manager, Study Start Up Operations

About Us

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.

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.