Sr. Project Manager

Heart Rhythm Clinical Research Solutions is a full-service CRO that combines science, data, and collaboration to drive innovation in cardiovascular care. The Senior Project Manager is responsible for planning, coordinating, and executing clinical trials while ensuring compliance with regulatory standards and effective communication among stakeholders.

Responsibilities:

• 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
• Acts as the strategic liaison with Client/Financial Entity, provides guidance on trial/registry direction, innovations, and long-term planning
• Oversees planning, execution, and completion of cardiac-focused medical device clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements
• Ensures applicable study training is assigned to project team members in collaboration with Quality
• Develops project plans, risk management strategies, and contingency plans to address potential trial challenges
• Ensures the accuracy and integrity of clinical trial data
• Act as the primary point of contact for Clients/Financial Entities, providing project updates, strategic guidance, and risk mitigation strategies
• Lead cross-functional teams that include clinical operations, data management, biostatistics, regulatory affairs, and quality assurance
• Provides oversight of direct reports including conducting performance reviews/support goal setting
• Demonstrates accountability by completing all mandatory training on time and in accordance with company requirements
• Regular and reliable attendance
• Other duties as assigned

Requirements:

• Bachelor's degree in Life Sciences or related field
• 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
• PMP, master's degree, or relevant certification is preferred. However, a combination of experience and/or education will be taken into consideration