Remote Early-Phase Clinical Project Leader

Parexel; Pierre (SD); Remote; USD 110,000 - 135,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings

Work/Life Balance

401(k) with Company match

Pet Insurance

Job summary

Parexel in the United States is seeking a Project Manager, Early Phase to join our team in a remote capacity based in CA, TX, or CO. You will lead Parexel and sponsor teams to develop and execute tailored operational and logistical strategies for early phase clinical trials.

You will own sponsor relationships, manage study timelines and budget, ensure compliance with ICH-GCP, and drive operational excellence from startup through closeout.

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 collaboration

Communication

Risk management

Microsoft Office

Education

Bachelor's degree in a science-related field

Tools

Microsoft Office

Job description

Parexel in the United States is seeking a Project Manager, Early Phase to join our team in a remote capacity based in CA, TX, or CO. You will lead Parexel and sponsor teams to develop and execute tailored operational and logistical strategies for early phase clinical trials.

You will own sponsor relationships, manage study timelines and budget, ensure compliance with ICH-GCP, and drive operational excellence from startup through closeout.