Clinical Project Manager - Early Phase Trials

Parexel is a leading company focused on improving the world's health through clinical trials and regulatory consulting. They are seeking a Clinical Project Manager for Early Phase Trials to lead project teams, ensuring successful execution of clinical operations and compliance with regulations while managing sponsor relationships and project budgets.

Responsibilities:

• Own the sponsor relationship and manage sponsor communication
• Serve as the central point of contact and escalation for functional teams
• Proactively communicate project progress, risks, and solutions to sponsors and internal teams
• Lead regular meetings with sponsors and project teams to ensure objectives are met
• Review relevant materials and attend strategy meetings
• Prepare for Bid Defense and develop project management strategies
• Attend Bid Defense and handover meetings
• Manage study start-up activities and ensure best practices are implemented
• Oversee site selection strategy and review project contracts and budgets
• Set up project teams and systems, and manage IRB/EC and RA approval processes
• Lead internal and sponsor kick-off meetings and ensure team understanding of project scope and expectations
• Lead projects to completion within budget and schedule, ensuring contract specifications are met
• Provide performance feedback and ensure project tracking using CTMS
• Monitor study timelines, recruitment, retention, and data cleaning
• Prepare for audits/inspections and manage project budgets
• Oversee administrative closeout procedures and ensure project documentation is archived
• Lead end-of-study meetings to document lessons learned
• Identify potential project risks and implement contingency plans
• Mitigate risks and keep clients informed throughout the study life cycle
• Contribute to SOP development and provide oversight and training to Associate PMs and Project Assistants

Requirements:

• 2 years of Project Management experience with Parexel or 3 to 5 years in related fields
• Experience as a Functional Team Leader or in coordinating clinical trials
• Knowledge of ICH-GCP and pharmaceutical industry regulations
• Proficiency in MS-Office products
• Bachelor's degree in a science-related field or equivalent work experience
• Leadership skills to lead virtual teams across locations and cultures
• Negotiation and influence skills to achieve results
• Decision-making skills in ambiguous situations
• Problem-solving and root cause analysis skills
• Excellent interpersonal, oral, and written communication skills
• Time management and organizational skills
• Strategic thinking and financial management skills
• Advanced degree preferred
• Additional business degree or PMP certification is an advantage
• Scientific/Medical/Pharmacology background is an advantage