Study Start-up Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and oversee regional Site Start-up Unit (SSU) initiatives, crafting start-up strategies for country and site activation in studies of moderate scope and complexity.

• Engage in Sponsor meetings related to study start-up, addressing operational targets, risk mitigation, client expectations, communication, reporting, and metrics.

• Collaborate with Functional Leads and SSU team members to identify and rectify study start-up challenges.

• Supervise country and site feasibility assessments, analyzing site capabilities, regulatory and IRB/IEC considerations, as well as study-specific requirements.

• Coordinate with internal teams to confirm site recommendations and ensure alignment with study strategies.

• Drive the regional strategy for Regulatory and IRB/IEC submissions and approvals, managing timelines at the country level.

• Oversee the preparation and approval processes for Regulatory and IRB/IEC submissions.

• Gather cross-functional input to create thorough and accurate submission packages.

• Manage the development, adaptation, review, negotiation, and approval of Informed Consent Forms (ICFs).

• Oversee the requirements for Site Essential Documents, including templates, collection, review, approval, and quality checks.

• Lead site budget and contract negotiations, secure Sponsor and Rho Legal approvals, and file completed documentation.

• Collaborate with departments, clients, and stakeholders on site budget and contract templates and negotiation tools.

• Provide updates to Sponsors and internal teams regarding negotiation progress and expected timelines.

• Maintain SSU systems and analyze study start-up progress metrics in relation to targets and timelines.

• Ensure accurate documentation and timely transitions to Sponsors and internal project teams.

• Act as the primary contact for client-related study start-up matters.

• Partner with Clinical Team Leads, Clinical Research Associates (CRAs), and clients to strategize Site Initiation Visits and Site Activation timing.

• Assist in business development through proposal and bid defense initiatives.

• Provide operational oversight, guidance, feedback, and coaching to SSU Associates.

• Monitor the quality of SSU Associate work and offer performance coaching.

• Lead project team meeting components, delegate responsibilities, and clarify task assignments.

⛳️ Requirements

• A Bachelor’s Degree coupled with a minimum of 4 years of clinical research experience, including at least 3 years of clinical study start-up experience; global study start-up experience is preferred.

• A solid understanding of relevant international and local Regulatory and IRB/IEC requirements and guidelines (e.g., ICH; GCP, and/or EU Directives).

• Comprehensive knowledge of Regulatory and IRB/IEC submission processes for designated countries.

• Ability to engage in strategic and innovative risk management and contingency planning.

• Excellent written, verbal communication, and presentation abilities.

• Capacity to convey complex ideas to study personnel, internal teams, and Sponsor members.

• Strong organizational skills with the ability to prioritize across multiple studies.

• Interpersonal skills that facilitate effective collaboration.

• Strategic, tactical, and critical thinking capabilities.

• A client-focused, action-oriented work ethic.

• Proficient in computer and internet skills.

• Familiarity with MS Office applications, including 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