Clinical Trial Start-Up Lead

Position: Clinical Trial Start-Up Lead Location: 1 DNA Way, South San Francisco, CA 94080 Duration: 12-month contract (with potential for extension or conversion) Compensation: $46.87 – $87.73/hr (W2) Benefits: Weekly pay, medical, dental, and vision coverage Job Overview The 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 Responsibilities Study Start-Up Strategy & Execution Lead 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 Management Manage clinical trial submissions, amendments, and regulatory coordination Ensure accurate documentation, timely responses to regulatory queries, and lifecycle support Informed Consent Form (ICF) Oversight Lead preparation, submission, and archiving of ICFs Ensure compliance with corporate standards and regulatory requirements Site Activation & Compliance Oversee 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 Management Develop 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 Oversight Monitor payment processes, reporting, and reconciliation Ensure compliance with financial and regulatory requirements Process Improvement & Collaboration Identify 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 Qualifications Bachelor’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 & Competencies Excellent communication and stakeholder management skills Strong analytical, organizational, and problem-solving abilitiesExperience 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) #J-18808-Ljbffr Creative Solutions Services, LLC