Sr. Clinical Research Project Manager

iRhythm Technologies, Inc. • Deerfield, IL

1d • $115,000 - $149,000 • Remote

About The Position

We are seeking a highly experienced and motivated Sr. Clinical Research Project Manager (Sr. CRPM) to oversee the planning, execution, and completion of complex clinical research projects. The Sr. CRPM will be responsible for leading cross-functional teams, managing study budgets and timelines, and ensuring that studies are conducted in compliance with regulatory requirements and guidelines, including Good Clinical Practice (GCP) guidelines.

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, with a proven track record of managing complex clinical research projects.
• In-depth knowledge of regulatory requirements and Good Clinical Practice (GCP) guidelines.
• Excellent organizational, communication, and problem-solving skills, with the ability to prioritize and multitask effectively.
• Strong attention to detail and accuracy.
• Proficiency with Microsoft Office Suite and 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.

Nice To Haves

• Experience with ISO 14155 and other international guidelines desirable, but not required.

Responsibilities

• Lead the planning, execution, and oversight of all domestic and international clinical research types (i.e., Sponsor-initiated, Research as a Service (RaaS) and Investigator-initiated (IIR) studies), including coordinating the activities of cross-functional teams, ensuring compliance with protocols and standard operating procedures, and monitoring progress against project timelines and budgets.
• Develop and review study-related documents, such as 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 clinical research organizations (CROs) and other external service providers, to ensure that services are provided in a timely and cost-effective manner.
• Manage study monitors and provide guidance and support as needed.
• Develop and maintain relationships with key stakeholders, including study coordinators, investigators, and sponsor representatives.
• Ensure that studies are conducted in compliance with regulatory requirements and guidelines, including GCP guidelines.
• Manage study budgets and timelines, including forecasting and tracking expenses and negotiating study contracts.
• Develop risk management plans and mitigation strategies.
• Develop and implement quality control measures to ensure the accuracy and completeness of study data.
• Prepare study reports, presentations, and publications.
• Mentor and train junior staff members.

Benefits

• A job that doesn't feel like a job, working with an impressive group that feels more like friends than colleagues who are highly collaborative and supportive.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior