Project Manager - Early Phase Clinical Research

About the Role

We are seeking a Project Manager, Early Phase to join our team in a remote capacity, based in CA, TX, or CO. As a Project Manager, you will lead Parexel and sponsor teams in developing and executing tailored operational and logistical strategies for early phase clinical trials or programs. You will be accountable for delivering projects on time, within budget, and to the highest quality standards while maintaining compliance with ICH, GCP, applicable regulations, SOPs, contract terms, system requirements, and metrics.

Key Responsibilities

• Own the sponsor relationship, serve as the central point of contact and escalation, and proactively communicate project progress, risks, and solutions.
• Lead regular sponsor and project team meetings to align objectives, responsibilities, timelines, and expectations.
• Contribute to pre-award strategy by reviewing relevant materials, preparing project management strategies, and participating in Bid Defense and handover meetings.
• Lead study start-up activities, including site selection strategy, contract and budget review, project team and system setup, and IRB/EC and regulatory authority approval processes.
• Direct internal and sponsor kick-off meetings and ensure the project team understands the study scope, operational plan, and delivery expectations.
• Lead clinical trials or programs through completion within budget and schedule while ensuring all contract specifications and quality requirements are met.
• Monitor study timelines, recruitment, retention, data cleaning, project performance, and CTMS tracking, and provide performance feedback to project team members.
• Manage project financials, including budgets, revenue recognition, milestone payments, and monthly pass-through invoices.
• Prepare projects for audits and inspections, oversee administrative closeout and document archiving, and lead end-of-study lessons learned meetings.
• Identify project risks, develop and implement contingency plans, mitigate issues throughout the study life cycle, and keep clients informed.
• Contribute to SOP development and provide oversight and training to Associate Project Managers and Project Assistants.

Candidate Profile

You'll thrive in this role if you bring strong clinical research and project management expertise, the ability to lead cross-functional teams and build credible sponsor relationships, clear proactive communication, a strong focus on quality and compliance, and comfort managing project systems, operational metrics, contracts, budgets, and financial processes.