Project Manager, Early Phase

Job description

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 : - 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.

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.