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