Clinical Project Manager

1w1 week ago

Alto Neuroscience

Mountain View, US · Full-time · $125,000 – $170,000

About this role

The Clinical Project Manager handles end-to-end clinical trial delivery with operational oversight of clinical development programs in a hybrid outsourced model. This role ensures high-quality, timely, and compliant execution of studies per internal SOPs, ICH/GCP guidelines, and regulations. It demands proactive risk management and issue escalation.

Day-to-day involves leading study oversight from start-up to close-out, developing operational plans like monitoring and vendor oversight strategies, and conducting feasibility assessments with data-driven enrollment planning. Professionals manage budgets, forecasts, and resource capacity across teams and CRO partners while applying metrics to optimize execution.

Collaboration spans internal functions including Program Physician, Regulatory, Data Management, and Quality Assurance to deliver protocols, IBs, ICFs, and study reports on time. Vendor management includes CRO oversight, performance metrics review, site monitoring, and participation in visits or audits as needed.

In a people leadership capacity, guide cross-functional teams, manage direct reports, and support training and development. The role fosters alignment and knowledge sharing for consistent clinical operations priorities in a dynamic pharma environment. Opportunities arise in program-level planning with leadership.

Requirements

Experience providing operational oversight for clinical studies in hybrid outsourced models
Knowledge of ICH/GCP guidelines, internal SOPs, and regulatory requirements for clinical trials
Proficiency in developing clinical study documents including protocols, IBs, ICFs, and CRFs
Skills in CRO and vendor management, including selection, governance, and performance oversight
Ability to conduct feasibility assessments, enrollment forecasting, and risk-based monitoring strategies
Expertise in clinical operations planning, budgeting, resource forecasting, and metrics-driven optimization
Demonstrated cross-functional collaboration with regulatory, data management, and quality teams

Responsibilities

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
Develop and own study-level operational plans, including monitoring strategies, vendor oversight plans, and risk management plans
Lead feasibility assessments, site selection strategies, and enrollment planning using data-driven approaches
Provide CRO and vendor oversight, including review and execution of vendor oversight plans and performance metrics
Foster cross-functional collaboration and manage assigned direct reports with oversight of their deliverables and development