The Clinical Project Manager is responsible for supporting the delivery of Qureight’s clinical study services to pharmaceutical and CRO customers, working in close collaboration with teams across the business. They are experienced in managing clinical trial imaging services, and have experience in qualifiying, coordinating and managing clinical study sites. A positive and can-do attitude, alongside in-depth understanding of clinical study quality and regulatory standards is essential to the role. This is a hybrid role based out of the Cambridge office.
Requirements
Roles and Responsibilities:
- Work with partners and customers to understand study goals and objectives, helping to establish the clients’ requirements.
- Be responsible for management and execution of assigned clinical studies and projects from kick-off to close-out, acting as the main point of contact.
- Conduct projects in accordance with Good Clinical Practice (GCP) guidelines and all relevant regulations, including ISO27001 standards and data privacy regulations.
- Track and report project milestones and maintain relevant internal systems with project specific information.
- Create, review, and maintain project wide documentation.
- Evaluate departmental processes and drive continuous improvement and operational efficiency, including revising work instructions and SOPs as necessary.
- Ensure correspondence and documentation is maintained in appropriate internal systems, and in line with ICH GCP.
- Coordinate all site onboarding activities for assigned projects.
- Support site evaluation and qualification (i.e. qualification of scan equipment and protocols, and user access to imaging platforms).
- Provide project specific training to site staff, ensuring training is documented in line with ICH GCP.
- Track site onboarding progress and status resolving any issues that arise and escalating as necessary.
- Maintain essential site documents, updating and sharing as needed.
- Respond to and resolve queries or issues in a timely and efficient manner.
- Build strong relationships with all stakeholders (at site, with sponsors, with customers and within Qureight) maintaining transparent and consistent communication throughout.
- Support general Clinical Operations activities as needed.
Essential Experience and Skills:
- Minimum of 3 years of clinical trial project and site management experience in an imaging Clinical Research Organisation or Core Imaging Lab.
- Experience of clinical study site set up and delivery for imaging studies, e.g. site qualification, site training, support and site close out.
- Strong project management skills with ability to prioritise tasks effectively.
- Demonstrated ability to cultivate and maintain key stakeholder relationships, both internally and externally.
- Expert knowledge of ICH Good Clinical Practice (GCP) with evidence of recent training.
- Experience working within a Quality Management System (QMS), e.g., ISO 9001, ISO 13485.
- Knowledge of relevant regulatory, compliance and industry standards, e.g. 21 CFR Part 11.
- Strong interpersonal skills with a high proficiency in written and verbal communications.
- Track record of working effectively and problem solving in a highly technical and innovative environment, demonstrating a good attention to detail.
- Evidence of a can-do attitude with a tenacity and drive to achieve objectives.
- Experience of, or formal qualification in, project management.
Qualifications / Education:
- A bachelor’s degree (or higher) in a relevant biomedical or healthcare-related field.
- Good Clinical Practice (GCP) training.
