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 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)