Job Title: Manager, Study Start Up Operations
Position OverviewThe 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
QualificationsEducation & ExperienceRequired:- 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/LicensureRequired:- 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
No nights, weekends, or holidays. Comprehensive benefits package.Join UsIf 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.
