Senior Clinical Research Project Manager

🕒 4 days ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $115k - $149k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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iRhythm Technologies, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2006

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

iRhythm Technologies, Inc. is a medical technology company that specializes in digital healthcare solutions for the management of cardiac arrhythmias. The company is best known for its ZioSuite, a comprehensive platform designed to deliver a streamlined solution for assessing heart health through advanced analytics and patient-centered data collection. iRhythm focuses on improving patient outcomes and optimizing the efficiency of healthcare providers through innovative technology in the cardiac monitoring space.

📋 Description

• Lead the planning, execution, and oversight of domestic and international clinical research studies, including Sponsor-initiated, Research as a Service (RaaS), and Investigator-initiated studies • Coordinate cross-functional teams and monitor progress against project timelines and budgets • Develop and review protocols, informed consent forms, case report forms, and study manuals • Lead study start-up activities, including site identification, feasibility assessment, and study initiation visits • Manage study vendors, including CROs and other external service providers • Manage study monitors and provide guidance and support • Develop and maintain relationships with study coordinators, investigators, and sponsor representatives • Ensure compliance with regulatory requirements, GCP guidelines, protocols, and standard operating procedures • Manage study budgets and timelines, including forecasting, expense tracking, and contract negotiation • Develop risk management plans and mitigation strategies • Develop and implement quality control measures for study data • Prepare study reports, presentations, and publications • Mentor and train junior staff members • Report to the Manager, Clinical Research Projects and collaborate with the clinical research team

🎯 Requirements

• Bachelor's degree in a health-related field or relevant work experience in clinical research • 8+ years of experience in clinical research project management or related field • Proven track record of managing complex clinical research projects • In-depth knowledge of regulatory requirements and Good Clinical Practice (GCP) guidelines • Experience with ISO 14155 and other international guidelines desirable, but not required • Excellent organizational, communication, and problem-solving skills • Ability to prioritize and multitask effectively • Strong attention to detail and accuracy • Proficiency with Microsoft Office Suite • Experience with electronic data capture systems and clinical trial management systems • Ability to lead cross-functional teams and work effectively in a fast-paced, deadline-driven environment • Experience with clinical trial budgets and financial management • Strong leadership skills, with the ability to mentor and train junior staff members • Willingness to learn and take on new challenges • Willingness to work occasional evenings or weekends • Willingness to travel, potentially internationally

🏖️ Benefits

• Fully remote position • Occasional travel to team offsite events and conferences • Inclusive workforce • Equal Opportunity Employer • Reasonable accommodations for qualified individuals with disabilities