Study Start-up Lead

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $75k - $95k / year

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Rho

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 1984

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Rho is a financial technology company that provides integrated banking solutions for businesses, combining modern banking with cash management and expense tracking. Their platform focuses on streamlining financial operations and offering a user-friendly interface for better control of company finances.

📋 Description

• Lead and manage regional SSU efforts and develop start-up plans for country and site activation on studies of moderate scope and complexity • Participate in Sponsor meetings regarding study start-up, including operational targets, delivery risk mitigation, client expectations, communication, reporting, and metrics • Partner with Functional Leads and SSU team members to identify and resolve study start-up issues • Oversee country and site feasibility activities and evaluate site capabilities, regulatory and IRB/IEC considerations, and study-specific requirements • Coordinate internal teams to confirm site recommendations and align with study strategy • Drive regional Regulatory and IRB/IEC submission and approval strategy and manage country-level timelines • Coordinate Regulatory and IRB/IEC submission preparation and approval activities • Coordinate cross-functional input to prepare complete and accurate submission packages • Coordinate ICF development, country adaptation, review, negotiation, and approval • Manage Site Essential Document requirements, templates, collection, review, approval, and quality checks • Drive site budgets and contract negotiations, obtain Sponsor and Rho Legal approval, and file completed documents • Collaborate with departments, clients, and stakeholders on site budget and contract templates and negotiation tools • Provide Sponsor and internal team updates on negotiation progress and anticipated timelines • Maintain SSU systems and analyze study start-up progress metrics against targets and timelines • Ensure accurate documentation and timely handoffs to Sponsor and internal project teams • Serve as the point of contact for client study start-up matters • Partner with Clinical Team Leads, CRAs, and clients on Site Initiation Visit and Site Activation strategy and timing • Support business development with proposal and bid defense efforts • Provide operational oversight, guidance, feedback, and coaching to SSU Associates • Oversee SSU Associate work quality and performance coaching • Lead components of project team meetings, delegate tasks, and clarify responsibilities

🎯 Requirements

• Bachelor’s Degree along with at least 4 years clinical research experience, with 3 years of clinical study start up experience; global study start up experience is preferred • Sound understanding of applicable international and local Regulatory and IRB/IEC requirements and guidelines (i.e., ICH; GCP, and/or EU; Directives) • Good knowledge of Regulatory and IRB/IEC submission processes for assigned countries • Strategic and creative risk management and contingency planning • Strong written, verbal communication, and presentation skills • Ability to express complex ideas to study personnel, internal and Sponsor team members • Strong organizational skills and ability to manage priorities across multiple studies • Interpersonal skills • Strategic, tactical, and critical thinking skills • Client-focused, action-oriented approach to work • Proficient computer and internet skills • Working knowledge of MS Office applications, such as MS Outlook, Word and Excel

🏖️ Benefits

• Medical insurance • Vision insurance • Dental insurance • HSA • FSA • EAP • Life insurance • Disability insurance • 401(k) • Paid time off • Holidays • Parental leave • Bereavement leave • Work-life balance flexibility

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