Clinical Project Manager

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.