Job Description
Note: The job is a remote job and is open to candidates in USA. Perceptive Inc. is seeking a Scientist specializing in MRI for clinical research projects. The role involves providing scientific input on clinical trials, developing imaging guidelines, and conducting training for project teams and reviewers.
- Responsibilities
- Independently author internal and external facing documents and material such as: Standardized/Harmonized imaging parameters β Image Acquisition Guidelines (e.g., develop imaging parameters for specific clinical protocols to ensure standardization of imaging techniques in multi-center trials)
- With supervision β Review and provide input to relevant project related documents such as: Project Plan, Site Operations Manual, if requested, Independent Review Charter, Image QC and processing instructions (QC Form), Reviewer Manual, if applicable, Clinical Data Transfer Instructions, if applicable
- With supervision: Create training material for and present to investigator sites, CRA and client (as needed) such as PowerPoint presentation, site guides on assessment criteria and imaging parameters
- With supervision: Create training material for and present to internal team on image acquisition parameters, quality control and image processing, e.g. image operations
- With supervision: Review requirement specifications of analysis application (including eCRF) and associated applications, and customization of relevant image viewing/analysis tools
- With supervision: Conduct User Acceptance Testing
- Review CVs of potential independent reviewers
- With supervision - prepare and conduct Independent Reviewer Trainings, including: Prepare Independent reviewer Training PowerPoint slides, Review/Edit training associated documentation, Select/Prepare training and testing cases for reviewer training, Lead training of independent reviewers on the use of imaging software, analysis applications, and implementation of the review criteria
- With supervision perform quality control and evaluation of the results of the independent review and provide necessary guidance and feedback to independent reviewers
- Identify non-compliances and non-conformances
- Review audit findings, determine the risks associated with those findings and ensure that corrective actions are carried out
- Participate in project related client meetings
- Effective and professional communication with internal and external stakeholders; act as a translator as needed
- Identify, evaluate and communicate potential risks related to deliverables as well as their mitigation
- Actively maintain and disseminate knowledge in one or more identifiable specialisms
- Skills
- Provide scientific input on projects for clinical trials where medical imaging and clinical data is used to evaluate efficacy and/or safety of investigational drugs or medical devices
- Work with the project team lead on project related aspects of documents, application development with supervision
- Lead the development of image acquisition guidelines, medical documentation, preparation and conduct of external project team training, central reviewer training and reviewer quality control from a medical / scientific perspective in consultation with the relevant internal support and stakeholders
- Independently author internal and external facing documents and material such as Standardized/Harmonized imaging parameters β Image Acquisition Guidelines
- Review and provide input to relevant project related documents such as Project Plan, Site Operations Manual, Independent Review Charter, Image QC and processing instructions, Reviewer Manual, Clinical Data Transfer Instructions
- Create training material for and present to investigator sites, CRA and client
- Review requirement specifications of analysis application and associated applications, and customization of relevant image viewing/analysis tools
- Conduct User Acceptance Testing
- Review CVs of potential independent reviewers
- Prepare and conduct Independent Reviewer Trainings
- Perform quality control and evaluation of the results of the independent review and provide necessary guidance and feedback to independent reviewers
- Identify non-compliances and non-conformances
- Review audit findings, determine the risks associated with those findings and ensure that corrective actions are carried out
- Participate in project related client meetings
- Effective and professional communication with internal and external stakeholders
- Identify, evaluate and communicate potential risks related to deliverables as well as their mitigation
- Actively maintain and disseminate knowledge in one or more identifiable specialisms
- Demonstrable ability to design and deliver training to a varied and global audience at all levels
- Demonstrable knowledge of medical terminology and practices
- Proven understanding of research methodologies and pragmatic application in a regulated environment
- Proven ability of using Microsoft Office products (including Word, Excel & PowerPoint)
- Excellent interpersonal, verbal and written communication skills
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Ability to work methodically in a fast-paced, time-sensitive environment
- Demonstratable ability to apply critical thinking to problems and tasks
- Ability to identify and implement process improvements
- Proactively participates in skills improvement training and encourages teams to participate
- Maintain an up-to-date awareness of trends, tools, technology, techniques, processes and developments within the Life sciences domain
- A self-starter and able to work under own initiative
- Experience using tools to communicate progress to Stakeholders
- Solid proven experience of working in and knowledge of medical imaging or clinical development in the life sciences industry and regulated environments
- Solid professional experience in the same or very similar role
- MS/MA, RPh with experience or BA/BS/RN/BSN/Technologist Certification with experience in imaging or clinical trials
- English: Fluent
- Candidates located in the following states: AZ, CT, DE, FL, GA, IL, MA, MO, NH, NJ, NC, PA, UT, VA are preferred
- US applicants must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future
- Experience as Advanced Imaging Cardiologist not only for MRI but for echo as well
- Experience with cardiac software such as Medis Suite MR, suiteHEART, etc
- Experience quantitative assessments of function, perfusion, flow, and mapping
- Company Overview
- Expanding on their combined 50-year history, Perceptive provides best-in-class specialist support to global pharmaceutical, biotech, and clinical research organizations, spanning the complete R&D lifecycle, from discovery and preclinical through clinical development to post marketing. It was founded in 1996, and is headquartered in London, England, GBR, with a workforce of 1001-5000 employees. Its website is https://www.perceptive.com.
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