Project Manager - Early Phase

at Parexel in Boise, Idaho, United States

Home Based (Preference for CA, CO, or TX locations)

The Project Manager for Early Phase (EP) leads Parexel and Sponsor teams by leveraging clinical research experience and project management skills to develop tailored solutions for sponsors. This role requires a deep understanding of business, knowledge, experience, and flexibility to make informed and effective decisions independently. The Project Manager ensures operational excellence and successful execution of clinical operations and logistical strategies for EP clinical trials or programs. They are accountable for the successful delivery of projects/programs on time, on budget, and to the highest quality, compliant with ICH , GCP , and other applicable regulations. The Project Manager also manages the financial aspects of projects, including revenue recognition, milestone payments, and monthly pass-through invoices, while ensuring compliance with relevant SOPs, contract terms, system requirements, and metrics.

Key Accountabilities :

Communication and Sponsor Liaison

+ Own the sponsor relationship and manage sponsor communication.

+ Serve as the central point of contact and escalation for functional teams.

+ Proactively communicate project progress, risks, and solutions to sponsors and internal teams.

+ Lead regular meetings with sponsors and project teams to ensure objectives are met.

Pre-award Activities

+ Review relevant materials and attend strategy meetings.

+ Prepare for Bid Defense and develop project management strategies.

+ Attend Bid Defense and handover meetings.

Project Planning & Initiation

+ Manage study start-up activities and ensure best practices are implemented.

+ Oversee site selection strategy and review project contracts and budgets.

+ Set up project teams and systems, and manage IRB /EC and RA approval processes.

+ Lead internal and sponsor kick-off meetings and ensure team understanding of project scope and expectations.

Project Implementation, Control & Evaluation

+ Lead projects to completion within budget and schedule, ensuring contract specifications are met.

+ Provide performance feedback and ensure project tracking using CTMS .

+ Monitor study timelines, recruitment, retention, and data cleaning.

+ Prepare for audits/inspections and manage project budgets.

Project Close-out

+ Oversee administrative closeout procedures and ensure project documentation is archived.

+ Lead end-of-study meetings to document lessons learned.