We’re on a mission to change the future of
clinical research. At Perceptive, we help the
biopharmaceutical industry bring medical
treatments to the market, faster.
Our mission is to change the world
but to do this, we need people like you.
Apart from job satisfaction, we can offer you:
YOURSELF
• 25 days’ holiday (with the option to buy more)
HEALTH
• Health Cash Plan
• Optional private health, dental insurance, and health screens
• Cycle to work scheme
WEALTH
• Generous pension scheme with up to 10% employer contribution
• Life assurance
• Season ticket loan
About the role
As a Principal Scientist, you will 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.
In this role, you will work with the project team to lead all project related aspects of documents, application development and (where applicable) quantitative analysis workflow development, independently.
In addition, you will 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.
Document Development
Independently author internal and external facing documents and material such as:
Standardized/Harmonized imaging parameters - Image Acquisition Guidelines (e.g. develop imaging parameters for specific clinical protocols to ensure standardization of imaging techniques in multi-center trials)
Document Review
Independently 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
Prepare and conduct internal and external trainings
Independently 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.
Independently create training material for and present to internal team on image acquisition parameters, quality control and image processing, e.g. image operations
Support application development
Independently review requirement specifications of analysis application (including eCRF) and associated applications, and customization of relevant image viewing/analysis tools
Independently conduct User Acceptance Testing
Participate in Independent Reviewer Selection
Review CVs of potential independent reviewers
Prepare and conduct Independent Reviewer Trainings
Independently 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
Independent Reviewer Performance Monitoring
Independently perform quality control and evaluation of the results of the independent review and provide necessary guidance and feedback to independent reviewers
Quality
Identify non-compliances and non-conformances
Review audit findings, determine the risks associated with those findings and ensure that corrective actions are carried out
Client Meetings
Participate in and significantly contribute to project related client meetings
Communication
Effective and professional communication with internal and external stakeholders; acts as a translator as needed
Identify, evaluate, communicate and mitigates potential risks related to deliverables.
Actively maintain and disseminate knowledge in one or more identifiable specialisms.
Ability to perform the tasks independently and able to work under own initiative
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
Must have the 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 their teams to participate
Maintain an up-to-date awareness of trends, tools, technology, techniques, processes and developments within the Life sciences domain
MD/PhD with relevant Clinical Research experience
OR MSc with considerable experience
OR BSc / Undergraduate degree in Nursing / Technologist Certification with substantial experience in imaging or clinical trials
Solid proven experience of working in and knowledge of medical imaging or clinical development in the life sciences industry and regulated environments.
Experience using tools to communicate progress to stakeholders.
English: Fluent
Come as you are.
We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.