Clinical Project Manager

Alto Neuroscience•Mountain View, CA

6d•$125,000 - $170,000•Hybrid

About The Position

The Clinical Project Manager is responsible for the end-to-end clinical trial delivery and provides operational oversight of clinical development programs conducted in a hybrid outsourced model. This role ensures high-quality, timely, and compliant execution of clinical studies in accordance with internal SOPs, ICH/GCP guidelines, and regulatory requirements.

Requirements

BS or BA in Life Sciences or related field (or equivalent experience)
Minimum 8+ years of clinical experience in pharmaceutical or biotech environments with increasing levels of responsibility
Demonstrated knowledge of multiple aspects of clinical research operations
Data-driven mindset with experience using metrics and analytics to drive decisions
Strong working knowledge of ICH/GCP, ICH E6, and regulatory requirements
Proven ability to lead cross-functional teams and manage external vendors
Experience managing and developing direct reports preferred

Responsibilities

Clinical Program & Study Oversight
Provide operational leadership and oversight for clinical studies from start-up through close-out and reporting
Ensure clinical studies are executed in compliance with internal SOPs, ICH/GCP guidelines, and protocol requirements
Identify study- and program-level risks and develop and implement mitigation strategies
Escalate site, vendor, and study issues appropriately and proactively
Clinical Operations Strategy, Planning & Analytics
Develop and own study-level operational plans, including monitoring strategies, vendor oversight plans, communication plans, and risk management plans
Lead feasibility assessments, site selection strategies, and enrollment planning using data-driven approaches
Own resource forecasting and capacity planning across internal teams and CRO partners
Develop and manage study budgets, forecasts, and change orders in collaboration with Finance and leadership
Apply operational metrics and performance data to continuously optimize study execution and decision-making
Support program-level operational planning in collaboration with Clinical Operations leadership
Collaborate with internal functional representatives (e.g., Program Physician, Regulatory, Data Management, Medical Writing, Legal, Finance, Quality Assurance, CMC, Clinical Supply) to ensure proper conduct and timely completion of deliverables
Clinical Study Documentation & Data Collaboration
Coordinate and contribute to the development of clinical study documents, including protocols, Investigators Brochures (IBs), informed consent forms (ICFs), case report forms (CRFs), study plans, status reports, and clinical study reports
Collaborate with Data Management to ensure development of CRFs and related plans for appropriate data collection, management, and analysis
Vendor, Site & Monitoring Oversight
Provide CRO and vendor oversight, including review and execution of vendor oversight plans and performance metrics
Act as the primary operational point of contact for CROs, functional service providers, and other vendors
Lead vendor selection, scope definition, governance, and ongoing performance management
Ensure CRO and vendor deliverables meet quality, timeline, and cost expectations
Provide strong oversight of site management and monitoring activities, including CRA performance and workload
Participate in Site Initiation Visits, co-monitoring visits, audits, and inspections as needed
Ensure monitoring strategies are appropriately risk-based and consistently executed
People Leadership
Foster cross-functional collaboration by guiding, influencing, and supporting team members outside of direct reporting lines to ensure alignment, knowledge sharing, and consistent execution of clinical operations priorities
Manage assigned direct reports and provide oversight of their responsibilities, deliverables, and professional development
Support training, mentoring, and performance management of clinical operations staff