[Hiring] Project Manager - Early Phase Clinical Research @Parexel

Role Description

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. This role offers the opportunity to own sponsor relationships, guide cross-functional teams throughout the full study life cycle, manage project financials, and contribute to operational excellence in early phase clinical research.

Key Responsibilities (includes but not limited to):

• 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.

Qualifications

• Strong clinical research and project management expertise, with the judgment and flexibility to make informed decisions independently.
• The ability to lead cross-functional Parexel and sponsor teams and build credible, productive sponsor relationships.
• Clear, proactive communication and the ability to manage priorities, risks, escalations, and solutions across the study life cycle.
• A strong focus on quality, compliance, operational excellence, and on-time, on-budget delivery.
• Comfort managing project systems, operational metrics, contracts, budgets, and financial processes.

Requirements

• 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.

Benefits

• Health, Vision & Dental Insurance
• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Work/Life Balance
• 401(k) with Company match
• Pet Insurance