Project Manager - Early Phase Clinical Research

Parexel; Helena (MT); 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 seeks a Project Manager, Early Phase to join our team in a remote capacity, based in CA, TX, or CO. You will guide Parexel and sponsor teams in developing and executing tailored operational and logistical strategies for early phase trials, delivering high-quality results on time and within budget.

You will manage sponsor relationships, lead cross-functional teams, ensure compliance with ICH/GCP and regulations, oversee budgets and milestones, and drive operational excellence throughout

Qualifications

• Bachelor's degree in a science-related field is required.
• 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.
• Experience coordinating clinical trials.

Responsibilities

• Own sponsor relationship and communicate progress, risks, and solutions.
• Lead sponsor and project team meetings to align objectives, responsibilities, timelines, and expectations.
• Contribute to pre-award strategy and Bid Defense activities.
• Lead study start-up activities including site selection, budgets, and regulatory approvals.
• Direct internal and sponsor kick-off meetings and ensure study scope and delivery.
• Manage trials to complete within budget and schedule with quality.
• Monitor study timelines, recruitment, data cleaning, and CTMS tracking.
• Manage project financials including budgets, revenue, milestones and invoicing.
• Prepare projects for audits and inspections and lead end-of-study lessons learned.
• Identify risks and implement contingency plans across the study life cycle.
• Provide oversight and training to junior project staff.

Skills

Clinical research

Project management

Communication

Education

Bachelor's degree in science

Tools

Microsoft Office

Job description

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.

About the Role

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 too):

• 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.

Candidate Profile

You’ll thrive in this role if you bring:

• 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.

Required 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 rials.
• Knowledge of ICH-GCP and pharmaceutical industry regulations.
• Proficiency in Microsoft Office products.

Benefits and Compensation

• 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

The potential base pay range for this role is $110,000 to $135,000. The actual salary offered may vary within this range based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location. Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions. We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

#LI-REMOTE

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.