Project Manager - Early Phase Clinical Research
About The Position
Parexel is seeking a Project Manager, Early Phase to join its team remotely, based in California, Texas, or Colorado. The role leads Parexel and sponsor teams in developing and executing operational and logistical strategies for early-phase clinical trials or programs. The Project Manager is accountable for delivering projects on time, within budget, and to quality standards while maintaining compliance with ICH-GCP, applicable regulations, SOPs, contract terms, system requirements, and metrics. The position includes ownership of sponsor relationships, leadership of cross-functional teams through the full study life cycle, management of project financials, and contributions to operational excellence in early-phase clinical research. Parexel is a global clinical development partner serving the life sciences industry. It reports having more than 22,000 employees worldwide and partners with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials.
Requirements
- Bachelor's degree in a science-related field.
- Two years of Project Management experience with Parexel, or 3 to 5 years of experience in related fields.
- Early-phase experience.
- Experience as a Functional Team Leader or in coordinating clinical trials.
- Knowledge of ICH-GCP and pharmaceutical industry regulations.
- Proficiency in Microsoft Office products.
Nice To Haves
- Site-level experience is highly preferred.
Responsibilities
- Own the sponsor relationship as the central contact and escalation point, 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 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 meeting contract specifications and quality requirements.
- 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.
Benefits
- Health, vision, and dental insurance.
- Tuition reimbursement.
- Vacation, holiday, and sick time.
- Flexible Spending and Health Savings Accounts.
- Work/life balance.
- 401(k) with company match.
- Pet insurance.
- Life insurance.
- Some roles may be eligible for additional incentives, bonuses, or other compensation programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
