Project Manager - EP

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.

Originally posted on Himalayas