Clinical Project Manager

Clinical Project Manager

This role offers the opportunity to lead the end-to-end delivery of clinical trials within a dynamic pharmaceutical and biotechnology environment. You will provide operational leadership across studies from start-up through close-out, ensuring quality, compliance, and timely execution. Working within a hybrid outsourced model, you will coordinate CROs, vendors, sites, and cross-functional internal teams. The role combines strategic planning, risk management, budget ownership, operational analytics, and hands-on study oversight. You will use data and performance metrics to improve trial execution, anticipate challenges, and support informed program decisions. You will also contribute to the development of clinical study documentation and help build strong, accountable clinical operations teams. This is an impactful opportunity for an experienced clinical operations professional who thrives in complex, collaborative, and patient-focused environments.

Accountabilities

• Provide end-to-end operational leadership for clinical studies from study start-up through close-out and reporting, ensuring execution aligns with internal SOPs, protocols, ICH/GCP guidelines, and applicable regulatory requirements.
• Identify study- and program-level risks, establish mitigation strategies, and proactively escalate site, vendor, and operational issues when necessary.
• Develop and own study-level operational plans covering monitoring strategies, vendor oversight, communication, risk management, and execution timelines.
• Lead feasibility assessments, site selection strategies, and enrollment planning using data-driven approaches to support successful study delivery.
• Forecast resources and capacity across internal teams and CRO partners, ensuring appropriate staffing and operational coverage throughout the study lifecycle.
• Develop and manage study budgets, forecasts, and change orders in collaboration with Finance and senior leadership.
• Monitor operational metrics and performance data to identify trends, improve execution, and support evidence-based decision-making.
• Partner with Clinical Operations leadership and cross-functional stakeholders across Regulatory, Data Management, Medical Writing, Legal, Finance, Quality Assurance, CMC, Clinical Supply, and other functions to ensure timely completion of study deliverables.
• Coordinate and contribute to key clinical documents, including protocols, Investigator's Brochures, informed consent forms, case report forms, study plans, status reports, and clinical study reports.
• Collaborate with Data Management on case report forms and related plans to support effective data collection, management, and analysis.
• Serve as the primary operational point of contact for CROs, functional service providers, and other external vendors.
• Lead vendor selection, scope definition, governance, oversight, and ongoing performance management while ensuring deliverables meet quality, timeline, and cost expectations.
• Oversee site management and monitoring activities, including CRA performance and workload, and ensure monitoring strategies are appropriately risk-based and consistently executed.
• Participate in Site Initiation Visits, co-monitoring visits, audits, inspections, and other clinical activities as needed.
• Foster cross-functional collaboration and influence team members without direct reporting authority to maintain alignment and consistent execution.
• Manage assigned direct reports where applicable, supporting their responsibilities, professional development, training, mentoring, and performance management.

Requirements

• Bachelor's degree in Life Sciences or a related field, or equivalent professional experience.
• At least 8 years of clinical experience within pharmaceutical or biotechnology environments, with progressively increasing levels of responsibility.
• At least 2 years of clinical project management experience, with demonstrated ownership of clinical study delivery.
• Strong understanding of multiple aspects of clinical research operations, including study planning, site management, monitoring, vendor oversight, and study execution.
• Strong working knowledge of ICH/GCP, ICH E6, clinical research standards, and applicable regulatory requirements.
• Demonstrated ability to lead cross-functional teams and effectively manage CROs, vendors, and external partners.
• Data-driven mindset with the ability to use operational metrics, analytics, and performance data to identify risks and inform decisions.
• Strong organizational, project management, communication, and problem-solving skills, with the ability to manage multiple priorities in a complex clinical environment.
• Ability to influence stakeholders across functions and build collaborative relationships without relying solely on formal authority.
• Experience managing and developing direct reports is preferred.
• Global clinical development experience is a plus, particularly experience supporting Phase 2–3 studies.
• Willingness to work onsite in Mountain View, California, with remote work potentially considered.

Benefits

• Competitive salary range of $125,000–$170,000, depending on qualifications and experience.
• Opportunity to contribute to the development of innovative, personalized approaches to neuroscience and mental health treatment.
• Collaborative and cross-functional working environment.
• Opportunities to lead meaningful clinical development programs and work with experienced pharmaceutical and biotechnology professionals.
• Inclusive workplace committed to kindness, empathy, respect, and equal opportunity.
• Potential flexibility around remote work, depending on circumstances and role requirements.