About this role
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Key Accountabilities:
Communication and Sponsor Liaison
• 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.
Pre-award Activities
• Review relevant materials and attend strategy meetings. • Prepare for Bid Defense and develop project management strategies. • Attend Bid Defense and handover meetings.
Project Planning & Initiation
• 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.
Project Implementation, Control & Evaluation
• 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.
Project Close-out
• Oversee administrative closeout procedures and ensure project documentation is archived. • Lead end-of-study meetings to document lessons learned.
Risk Management
• Identify potential project risks and implement contingency plans. • Mitigate risks and keep clients informed throughout the study life cycle.
Administrative Tasks
• Contribute to SOP development and provide oversight and training to Associate PMs and Project Assistants.
Skills:
• 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.
Knowledge and Experience:
• 3 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.
Education:
• Bachelor’s degree in a science-related field or equivalent work experience. • Advanced degree preferred. • Additional business degree or PMP certification is an advantage. • Scientific/Medical/Pharmacology background is an advantage.