Senior Project Manager

Role Overview

The Senior Project Manager is a key role responsible for successfully planning, coordinating, overseeing, and executing clinical trials and registries in alignment with HRCRS standards and the Client’s/Financial Entity’s requirements. They serve as the primary liaison for all project-related communications, ensuring that studies are progressing according to plan and that all stakeholders are both informed and engaged.

What You Will Do

End-to-end project management from study start-up to closure, including ensuring that all relevant project plans are implemented as applicable (eTMF, Monitoring, & Data Management Plans, etc). Strategizes portfolio planning and ideas to support Client engagement, and oversees planning, execution, and completion of cardiac-focused medical device clinical trials.

Why It Might Be a Fit

This role requires strong leadership, strategic planning, and operational oversight to ensure the successful execution of global clinical trials/registries while maintaining compliance with regulatory standards. The Senior Project Manager provides strategic leadership, including portfolio planning, client/financial entity engagement, as well as high-level risk mitigation.

Requirements

• Bachelor’s degree in Life Sciences or related field
• PMP, master’s degree, or relevant certification is preferred
• Minimum of 8 years of experience in clinical project management within a Contract Research Organization (CRO), biotech, medical device, or pharmaceutical company
• In-depth understanding of clinical trials, including planning, execution, and regulatory requirements
• Strong knowledge of ISO 14155, ICH-GCP, FDA IDE trials, and global medical device regulations
• Strong project management skills, with the ability to manage multiple projects simultaneously
• Proven ability to manage multiple complex clinical studies simultaneously
• Excellent communication, negotiation, and leadership skills
• Experience with clinical trial management systems (CTMS), electronic data capture (EDC), and risk-based monitoring approaches

Benefits

• E-Verify participation