Clinical Research Project Manager - Remote in UK

Job Description

Clinical Research Project Manager - Remote in UK 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. Main duties of the job 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 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 position that may occasionally require evening or weekend work. About us 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 that distill data from millions of heartbeats into clinically actionable information. We focus on our people and our innovative technologies. We are passionate about improving and enhancing lives through better data and insights. We are continually developing a diverse and engaged workforce. We believe in the richness and quality of a working environment that is informed by people from all walks of life. Job responsibilities Clinical Research: Collaborate with a multidisciplinary team of professionals to initiate, implement, and conclude clinical research projects. Oversee junior members of the clinical study team in the planning, implementation, and management of clinical research projects, 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. Oversee and coordinate study vendors, such as clinical research organizations (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. 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. 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. Person Specification Experience 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. Experience with clinical trial budgets, contracts and financial management. Experience in multi-national regulatory requirements is a plus. Knowledge, skills and abilities 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. Strong leadership skills, with the ability to mentor and train junior staff members. Willingness to learn and take on new challenges. Qualifications Bachelor's degree in a health-related field or relevant work experience in clinical research. Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions. Contract Permanent Working pattern Full-time, Flexible working, Home or remote working #J-18808-Ljbffr