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