Clinical Research Project Manager - Remote in UK
NHS Jobs Bagshot
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.
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.
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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...
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in clinical research to join the Women’s Health Research Team at UCLH. The successful candidate(s) will play a key role in supporting an NIHR-funded study aimed at revolutionising the way neonatal jaundice is measured.
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