Through innovative eClinical solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market faster. With deep expertise in clinical development and more than 25 years of supporting trial sponsors and clinical research organizations (CROs), Calyx harnesses that intelligence and activates its potential to solve complex problems, deliver fast insights, and get new drugs to market every day
This role will be based at their modern state of the art office in Nottingham city centre which has excellent transport links as well as a great working environment and the feel of an innovative technology company. At present you would be working fully home based due to the current pandemic but expected to be office based when the situation improves.
As the Imaging Operations Lead you will be responsible for assisting the Project Manager in internal as well as external communication. This position provides study status monitoring and is a point person for internal escalation in regards to image processing, site management issues, and reviewer management issues, as applicable. You will also support the Project Manager with the set-up and oversight of internal study processes, timelines and deliverables.
- Monitor study progress and alert Project Manager and other involved study team members of any resourcing or timeline issues (e.g. review study status reports and perform random checks on data in the Tracking Application)
- Perform a regular quality check on central files, electronic and hard copy as applicable and take corrective action as required
- Support the Project Manager during internal and external study team calls (e.g. regular calls with client or clinical CRO), organizing the meetings and taking meeting minutes if required.
- Act as a back-up during out of office times of Project Manager and act as the point of contact for clients during Project Manager’s absence
- Support Project Manager in conducting the kick-off meeting and other study team meetings with internal and external study team members (e.g.preparing and presenting slides, organizing the meeting, taking and distributing minutes).
- Prepare and conduct trainings and presentations on Medical Imaging processes at Investigator Meetings or individual imaging specific meetings (remote or face to face) for site staff and CRAs
- Assist the process managers on image processing and site support questions
Project Monitoring & Reporting:
- Monitor that site qualification, image processing and query management are performed per the global guidelines, such as SOPs and work instructions, and are completed within the defined timelines
- Regularly review the status of site qualification, image processing, query management
- Act as a point of escalation for site related issues
- Support core group staff on answering site queries and requests
- Notify Project Manager and Process Manager/SciMed if team requires additional training on study specific tasks
Data Operations :
- Assist Project Manager in setting up the data reconciliation and data QC documentation
- Provide direction to the Team Leads or process group on data reconciliation activities
- Assist Project Manager in following up with Imaging Data Operations or SciMed for creation/review of data QC outlier report
- Act as a point of escalation for independent reviewer communication issues
- Support and/or perform case assignment for independent review on complex studies/ Provide direction to Team Leads for case assignment
- Act as liaison with 3rd party providers and/or consultants
- Bachelor’s Degree in a biological science, health science, technology or pharmacy or equivalent education with relevant work experience
- Strong interpersonal, verbal and written communication skills
- Sponsor focused approach to work
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Clinical trial and GCP experience preferred
- Medical Imaging experience preferred
- Excellent grasp of SOPs
- Excellent organizational skills
- Computer literate and familiar with the use of word processing, spreadsheet, presentation software and basic database applications
Knowledge and Experience:
- Must have previous work experience in clinical trials or in a relevant project management support role, ideally within Medical Imaging but not essential.
- Previous clinical project support or coordination experience would be ideal.
In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary and benefits package including 25 days holiday per year, pension scheme, life assurance, long term disability insurance, a health cash plan and other leading edge benefits that you would expect with a company of this type.
Apply today to begin your Calyx journey!
- Medical Imaging
- Project Management
- Project Support
- Project Coordination
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