Study Start-up Lead

Rho

. Lead and manage regional SSU efforts and develop start-up plans for country and site activation on studies of moderate scope and complexity .

Posted 11/12/2026full-timeRemote • United StatesSenior💰 $75,000 - $95,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical study start-up processes, including regulatory and IRB/IEC submissions, site feasibility evaluations, and budget negotiations. Exhibits strong communication, organizational, and strategic planning skills to effectively manage multiple studies and stakeholder expectations.

Highest-signal resume keywords

Clinical Study Start-Up ExperienceRegulatory Submission ProcessesIRB/IEC Requirements KnowledgeStrong Communication SkillsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperienceRegulatory Submission PreparationSite Feasibility EvaluationBudget NegotiationRisk ManagementContingency Planning

Soft Skills

Organizational SkillsInterpersonal SkillsStrategic ThinkingClient-Focused Approach

Tools & Technologies

MS Office ApplicationsSSU Systems

Industry Keywords

ICH GuidelinesGCPEU DirectivesStudy Activation Strategy

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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