Remote Early-Phase Clinical Trial Project Leader

Parexel; Salem (OR); Remote; USD 110,000 - 135,000; Full time

Benefits offered by this job

Health Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Life Insurance

Pet Insurance

Job summary

Parexel is expanding its Early Phase Project Manager role to lead sponsor relationships and drive study execution in a remote-capable environment within the United States. You will guide cross-functional teams, manage budgets, and ensure compliance with ICH-GCP across the study lifecycle.

The role emphasizes leadership of study start-up, timelines, regulatory approvals, and ongoing performance management, with a focus on timely, on-budget delivery and client satisfaction across Parexel’s global

Qualifications

• Bachelor's degree in a science-related field.
• 2 years of Project Management experience with Parexel or 3 to 5 years of experience in related fields.
• Early phase experience. Site level experience is highly preferred.
• Experience as a Functional Team Leader or in coordinating clinical trials.
• Knowledge of ICH-GCP and pharmaceutical industry regulations.
• Proficiency in Microsoft Office products.

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.

Skills

Project management

Cross-functional leadership

Regulatory knowledge

Communication

Budget management

Education

Bachelor's degree in a science-related field

Tools

Microsoft Office

CTMS

Job description

Parexel is expanding its Early Phase Project Manager role to lead sponsor relationships and drive study execution in a remote-capable environment within the United States. You will guide cross-functional teams, manage budgets, and ensure compliance with ICH-GCP across the study lifecycle.

The role emphasizes leadership of study start-up, timelines, regulatory approvals, and ongoing performance management, with a focus on timely, on-budget delivery and client satisfaction across Parexel’s global