Job Description
Title: Clinical Research Study Manager
Location: Remote, US
About iRhythm:
iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable bio sensing technology with powerful cloud-based data analytics and Artificial Intelligence capabilities. Our goal is to be the leading provider of ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 2 million patients and their doctors on a shorter path to what they both need answers.
About this role:
We are seeking an experienced and highly motivated Clinical Research Study Manager to oversee the planning, execution, and completion of clinical research projects. The Clinical Research Study Manager will be responsible for leading cross-functional teams to ensure that studies are conducted in compliance with regulatory requirements and guidelines, including Good Clinical Practice (GCP) guidelines. In this dynamic environment and fast-growing organization, you will have the opportunity to develop your technical skills, leadership competencies and advance your career.
Key Responsibilities:
- Lead the planning, execution, and oversight of clinical research projects, 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.
- Track and report on study progress, including enrollment, data collection, and data management.
- Prepare study reports, presentations, and publications.
- Ensure that studies are conducted in compliance with regulatory requirements and guidelines, including GCP guidelines.
- Develop and maintain relationships with key stakeholders, including study coordinators, investigators, and sponsor representatives.
Requirements:
- Bachelor’s degree in a health-related field or relevant work experience in clinical research.
- 5+ years of experience in clinical research project management or related field.
- 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.
- Ability to lead cross-functional teams and work effectively in a fast-paced, deadline-driven environment.
- Experience with clinical trial budgets and financial management.
- Willingness to learn and take on new challenges.