Project Manager – Early Phase Clinical Research

This is a fully remote position, open to applicants in California, +2 more states.

📋 Description

• Manage the sponsor relationship, acting as the primary point of contact and escalation.

• Provide updates on project status, potential risks, and proposed solutions.

• Facilitate meetings with sponsors and project teams.

• Play a role in pre-award strategy, project management approaches, Bid Defense, and handover discussions.

• Oversee study start-up tasks, including site selection, contract and budget analysis, team and system configuration, and securing IRB/EC and regulatory authority approvals.

• Direct the internal and sponsor kick-off meetings.

• Steer clinical trials or programs to completion within budget and timeline constraints.

• Track study timelines, participant recruitment and retention, data validation, project performance, and CTMS monitoring.

• Oversee project finances, including budgets, revenue recognition, milestone payments, and pass-through invoices.

• Prepare projects for audits and regulatory inspections.

• Manage administrative closeout and document storage.

• Conduct end-of-study lessons learned sessions.

• Identify potential risks, devise contingency plans, and address issues throughout the study lifecycle.

• Contribute to the development of Standard Operating Procedures (SOPs).

• Provide guidance and training to Associate Project Managers and Project Assistants.

⛳️ Requirements

• Bachelor’s degree in a science-related discipline.

• A minimum of 2 years of Project Management experience with Parexel or 3 to 5 years in related fields.

• Experience in early phase projects; site-level experience is strongly preferred.

• Background as a Functional Team Leader or in coordinating clinical trials.

• Familiarity with ICH-GCP and regulations governing the pharmaceutical industry.

• Proficient in Microsoft Office applications.

• Capacity to lead cross-functional teams from Parexel and sponsors.

• Skill in managing priorities, risks, escalations, and solutions throughout the study lifecycle.

• Experience in managing project systems, operational metrics, contracts, budgets, and financial processes.

🏝️ 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.

• Paid time off.

• Life insurance.

• Additional benefit offerings in accordance with applicable plans.