Clinical Research Project Manager

Job Summary and Purpose:

We are looking for an experienced and motivated Clinical Research Project Manager to collaborate with our international teams in establishing and executing clinical research initiatives for our internal, University, and Hospital customers.

In this position, the Project Manager will be responsible for ensuring that all studies comply with regulatory requirements and standards, including Good Clinical Practice (GCP) and ISO 14155:2020.

Additionally, this position will support for Health Economics and Outcomes Research, as well as Real World Evidence initiatives.

Reporting to the Sr. Director of Global Clinical Research Operations, the Project Manager will collaborate closely with the HEOR team and broader clinical research staff.

This is a full-time, remote within the UK position, that may occasionally require evening or weekend work.

Responsibilities: 

Clinical Research:

• Collaborate with a multidisciplinary team of professionals to initiate, implement, and conclude clinical research projects.
• May be required to oversee junior members of the clinical study team in the planning, implementation, and management of clinical research projects. This includes coordinating cross-functional team activities, ensuring adherence to protocols and standard operating procedures, and tracking progress in relation to project timelines and budgets.
• Oversee, develop and review study-related documents, such as protocols, informed consent forms, case report forms, and study manuals. These documents may be iRhythm study generated or may require review for our University and Hospital research teams.
• Oversee and coordinate study vendors, such as clinical research organisations (CROs) and other external service providers, to guarantee that services are delivered in a timely and cost-effective manner
• Initiate, track and review master research services agreements and scope of work documents to ensure timely submissions and execution. This position does not require any legal expertise but does require cross-functional collaboration skills.
• Develop and maintain relationships with key stakeholders, including study coordinators, investigators, and sponsor representatives.
• Conduct training, manage documentation, open sites and perform device accountability activities for the contracted studies.
• Ensure the iRhythm team is trained to conduct all studies assigned in compliance with regulatory requirements and guidelines, including appropriate guidelines.
• Assist in the preparation of clinical study reports, presentations, and publications.
• May be asked to develop risk management plans and mitigation strategies.

Health Economics Outcomes Research / Real World Evidence:

• Assist in collecting and managing real-world data (RWD) to support HEOR studies and RWE projects.
• Conduct literature reviews and support the development of health economic models or outcomes research protocols.
• Collaborate with cross-functional teams to ensure data collection aligns with HEOR and RWE objectives.
• Support the preparation of study-related documents, including RWE study protocols and HEOR deliverables like cost-effectiveness analyses.
• Oversee the design and execution of HEOR and RWE studies, ensuring alignment with regulatory and payer requirements.
• Manage cross-functional teams to deliver HEOR models, RWE analyses, and related publications.
• Ensure timely delivery of HEOR and RWE deliverables, such as value dossiers, real-world data analyses, and health outcomes reports.
• Coordinate with stakeholders to integrate RWE findings into clinical development and market access strategies.

About you: 

Required:

• Bachelor's degree in a health-related field or relevant work experience in clinical research.
• Extensive experience in clinical study management through an institution, sponsor company or Clinical Research Organization (CRO), with a proven track record of managing complex clinical study projects.
• In-depth knowledge of regulatory requirements, ISO 14155 and Good Clinical Practice (GCP) guidelines.
• Excellent organisational, communication, and problem-solving skills, with the ability to prioritise 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, contracts and financial management.
• Strong leadership skills, with the ability to mentor and train junior staff members.
• Willingness to learn and take on new challenges.

Desirable:

• Experience in multi-national regulatory requirements is a plus
• Prior management experience desirable

What’s in it for you:

iRhythm provides excellent benefits including Private Medical & Dental insurance, Pension Scheme (with company match), Employee Stock Purchase Plan, Life Assurance, Unlimited Access to Learning Platforms, Paid Holidays & Leave, Family Friendly Policies, Cultural Committee/Charity events, and so much!

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