Remote Project Manager, Early-Phase Clinical Trials

Parexel; Annapolis (MD); 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 is hiring a Project Manager, Early Phase for a remote-capable role based in the United States. You will lead Parexel and sponsor teams in developing strategic operational plans for early phase trials and programs, ensuring on-time, on-budget delivery and regulatory compliance.

You will manage sponsor relationships, oversee start-up activities, budgets, and CTMS, and guide cross-functional teams through the full study life cycle.

Qualifications

• Bachelor's degree in a science-related field.
• 2 years of Project Management experience with Parexel or 3–5 years in related fields.
• Early phase experience. Site level experience is highly preferred.
• 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

Communication

Sponsor management

Risk management

Education

Bachelor's degree in a science-related field

Tools

Microsoft Office

Job description

Parexel is hiring a Project Manager, Early Phase for a remote-capable role based in the United States. You will lead Parexel and sponsor teams in developing strategic operational plans for early phase trials and programs, ensuring on-time, on-budget delivery and regulatory compliance.

You will manage sponsor relationships, oversee start-up activities, budgets, and CTMS, and guide cross-functional teams through the full study life cycle.