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. 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.

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

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