Study Start-up Lead

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

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...

• 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