This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

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. 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.

• 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

Qualifications

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

Requirements

• This is a fully remote position and may be performed anywhere within the United States of America.
• Occasional domestic and international travel may be required for company meetings, site visits, audits, etc.

Company Description

This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.