Sr. Clinical Trial Manager/Associate Director

Role Summary

Sr. Clinical Trial Manager/Associate Director of Clinical Operations who leads cross-functional study teams to plan, execute, and deliver clinical trial operations across multiple studies. You will manage milestones, budgets, and vendor oversight while ensuring GCP, SOPs, and regulatory compliance, and you will foster collaboration across all aspects of study delivery. Location: US-based remote with quarterly visits to San Francisco, CA as needed.

Responsibilities

• Lead trial execution strategy and operational oversight by developing and driving the study operational plan, execution approach, and vendor-governance cadence, ensuring consistent progress toward major milestones and data deliverables
• Lead study planning and management by coordinating the development, review, and maintenance of key study documents (e.g., investigator brochures, protocols, ICFs, CRFs, CSRs, training manuals) and monitor study progress and timelines in partnership with the study and clinical leads
• Oversee quality control by developing, implementing, and training on SOPs, as well as creating monitoring and oversight processes to ensure compliance with GCP and regulatory guidelines
• Responsible for developing and managing clinical trial budgets, including site agreements, forecasting, accruals, and FTE allocations; reviewing vendor invoices and reconciling site payments to ensure accuracy and identify variances
• Build and maintain strong relationships with investigators and site staff, ensuring clear communication on study conduct, specimen tracking, and data review; organize investigator meetings as needed
• Provide oversight of CROs and vendors, including selection, contracting, onboarding, and performance management; conduct gap analyses, manage risks, and resolve issues proactively
• Partner with cross-functional teams to ensure efficient trial operations, including supply chain planning and coordination for clinical and non-clinical trial materials
• Directly manage and develop team members (as applicable) by hiring/onboarding, setting clear goals, coaching, providing timely feedback, and ensuring resourcing and prioritization to deliver trial milestones with quality

Qualifications

• Hold a bachelor’s degree in a scientific/medical field (or equivalent experience)
• At least 10-12 years of Clinical Operations experience within the biopharma industry
• Proven success leading cross-functional teams to deliver clinical trials from start-up through close-out, including financial oversight, data review, database lock, and reporting
• Strong vendor management expertise and experience with submission-ready eTMF, quality assurance, SOP development, and CAPA management
• In-depth knowledge of clinical trial design, protocol development, GCP, ICH E6 (R3), and GDPR, with preferred experience in rare/orphan disease studies
• Recognized for leadership, with excellent communication, organizational, and multitasking skills; proficient in tools such as Smartsheet is a plus
• Travel is required on a periodic basis to carry out responsibilities