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Rho Inc

Study Start-up Lead

Remote, United States

$75,000 to $95,000 USD / year

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Job details

Pay: $75,000 to $95,000 USD / year
Posting language: English
Posted: Nov 11, 2026

Original job description

The Study Start Up (SSU) team provides successful end to end coordination of Study Start-Up planning and execution activities including, but not limited to, investigator assessment and identification, pre-study development, site qualification, and site activation. SSU is a pivotal role requiring collaboration with internal and external stakeholders, working closely with the clinical study team, other internal functional areas, and Sponsors to support the study start-up process.

What You’ll Be Doing:

Project Oversight & Support

Leads and manages regional SSU efforts and develop Start-Up plans for country and site activation on studies of moderate scope and complexity
Participates in Sponsor meetings with respect to study start-up, including endorsement of the SSU operational targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics with oversight from a higher level SSU Lead when necessary
Partners closely with both Functional Leads and SSU team members to proactively identify and resolve study start up related issues

Feasibility & Site Identification

Oversees country and site feasibility activities, ensuring timely collection and evaluation of site capabilities, Regulatory & IRB/IEC considerations, and study-specific requirements; reviews / interprets site feasibility data to identify risks or barriers to site selection and activation
Coordinates with internal teams to confirm site recommendations and ensure alignment with study strategy

Regulatory & IRB/IEC Submissions & Approvals

Drives the regional Regulatory and IRB/IEC submission and approval strategy and manages country-level Regulatory and IRB/IEC submission and approval timelines
Participates in and coordinates country-level Regulatory and IRB/IEC submission preparation and approval activities, ensuring compliance with regional requirements
Coordinates cross-functional input (Regulatory, Medical, Legal, Clinical Operations) to prepare complete and accurate Regulatory and IRB/IEC submission packages

Site Essential Documents (SED) & ICF

Coordinate Informed Consent Form (ICF) development, country adaptation, review, negotiation, and approval with senior SSU support as needed.
Manage Site Essential Document (SED) requirements, templates, collection, review, approval, and second-level quality checks.

Budget & Contracts

Drives site budgets and contract negotiations, gains approval from Sponsor and Rho Legal, and files completed documents
Collaborates with applicable departments, Client, and stakeholders for obtaining site budget and contract templates and negotiation tools/trackers
Provides updates to Sponsor and internal team regarding negotiation progress and anticipated timelines

Systems, Metrics & Handoffs

Ensures that relevant SSU systems are maintained and up to date to analyze study start up progress metrics against targets/timelines
Ensures accurate documentation and timely handoffs to sponsor and internal project team

Stakeholder Engagement & Communication

Serves as the point of contact for client matters related to study start-up
Partners with Clinical Team Leads, CRAs, and the client to develop a strategy and timing for the Site Initiation Visit (SIV) and Site Activation
May support business development with proposal and bid defense efforts, including representing Rho in proposal meetings

Mentoring, Coaching, Leadership & Training

Provides operational oversight, guidance, and constructive feedback to SSU Associates on assigned projects
Oversees work quality of SSU Associates, providing clear expectations, timely feedback, and performance coaching
Leads components of project team meetings, delegating tasks appropriately and ensuring clarity of responsibilities
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 with the ability to express complex ideas to study personnel, internal and Sponsor team members
Strong organizational skills and ability to manage priorities across multiple studies and interpersonal skills
Strategic, tactical, and critical thinking skills with a client-focused action-oriented approach to work
Proficient computer and internet skills, including working knowledge of MS; office applications, such as MS Outlook, Word and Excel

A few more things to know about us:

Benefits: Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k). All employees are eligible for paid time off, holidays, parental leave and bereavement leave. Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work. As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $75,000 - $95,000 per year. EOE. Veterans/Disabled

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More about this job

Skills

Communication skills
Reporting
Regulatory compliance
Negotiation
Statistical quality control
Documentation
Stakeholder management
Sales
Coaching
Clinical research
Google Cloud
Risk management
Presentation skills
Organizational skills
Interpersonal skills
Critical thinking
Microsoft Outlook
Microsoft Word
Microsoft Excel

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Work requirements

Jobs in the United States