Clinical Trial Start-Up Lead

Position: Clinical Trial Start-Up LeadLocation: 1 DNA Way, South San Francisco, CA 94080Duration: 12-month contract (with potential for extension or conversion)Compensation: $46.87 - $87.73/hr (W2)Benefits: Weekly pay, medical, dental, and vision coverageJob OverviewThe Study Start-Up Lead (SSUL) is part of the Pharma Development Global Clinical Operations (PDG) team and plays a critical role in driving efficient and compliant clinical trial start-up activities. This position focuses on enabling timely study initiation, improving processes, and ensuring seamless collaboration across global, regional, and local stakeholders.Key ResponsibilitiesStudy Start-Up Strategy & ExecutionLead country-level study start-up strategies to ensure efficient and timely trial initiation Oversee execution of start-up activities, including risk mitigation and regulatory compliance Align country activities with global timelines and strategies Regulatory & Submission ManagementManage clinical trial submissions, amendments, and regulatory coordination Ensure accurate documentation, timely responses to regulatory queries, and lifecycle support Informed Consent Form (ICF) OversightLead preparation, submission, and archiving of ICFs Ensure compliance with corporate standards and regulatory requirements Site Activation & ComplianceOversee site documentation, validation, and compliance processes Manage local vendors (non-CRO) and ensure readiness for site activation Maintain knowledge of country-specific regulations and requirements Budgeting & Contract ManagementDevelop and manage site budgets based on Fair Market Value principles Lead contract negotiations, including CDAs, indemnity, and insurance documentation Ensure accurate contract tracking and forecasting Financial OversightMonitor payment processes, reporting, and reconciliation Ensure compliance with financial and regulatory requirements Process Improvement & CollaborationIdentify opportunities for automation, standardization, and innovation Collaborate with global teams and CROs to improve timelines and efficiencies Engage with regulatory authorities, ethics committees, and external stakeholders Leadership Responsibilities (if applicable)Provide coaching, mentorship, and performance management to team members Foster an inclusive and collaborative team environment Support employee development and address performance or operational challenges QualificationsBachelor's degree (BA/BS) required; advanced degree (MS, PhD, MD) preferred Experience in clinical trial start-up, regulatory submissions, and clinical operations Strong understanding of ICH-GCP and regulatory frameworks Experience managing vendors/CROs and cross-functional teams Leadership experience preferred for people management roles Skills & CompetenciesExcellent communication and stakeholder management skills Strong analytical, organizational, and problem-solving abilities Experience with clinical systems (e.g., Veeva Vault, CTIS, RIM) Ability to work in complex, global, matrix environments Fluent in English (additional local language proficiency required)

Created: 2026-05-09