Sr. Clinical Research Project Manager

Career-defining. Life-changing.

At iRhythm, you'll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what's possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career

About This Role:

About This Role:

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.

Essential Duties and 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.
• Travel up to 10% of the time to support project- and role-specific activities.
• 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.

Experience and Minimum Qualifications:

• 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.

Knowledge, Skills and Abilities:

• 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, 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.

Work Environment / Other Requirements:

This is a full-time, fully remote position that may require occasional evening or weekend work. The Sr. Clinical Research Project Manager will report to the Manager, Clinical Research Projects and work closely with the entire clinical research team. There are occasions where you may be asked to travel to team offsite events, conferences, or in the execution of your job. Travel may be international.

What's In It for You:

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.

Location:

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.

Estimated Pay Range

As a part of our core values, we ensure an inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills, and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.

iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system. If you need such an accommodation, you may contact us at taops@irhythmtech.com

About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm's vision is to deliver better data, better insights, and better health for all.

Make iRhythm your path forward. Zio, the heart monitor that changed the game.

There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact taops@irhythmtech.com. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.

For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121