Were 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
Starting at 14 days holiday per year rising to 22 days with increased addition to public holidays
Life Events Service Awards Company Outings
HEALTH
Medical plan
Annual medical check
WEALTH
Social security and public housing fund
Supplementary Housing Allowance
Life assurance
Critical illness cover
Key Accountabilities:
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
With minimal supervision - Review and provide input to relevant project related documents such as:
- Project Plan
- Site Operations Manual if requested 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
With minimal 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.
- 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
With minimal supervision
- Review requirement specifications of analysis application (including eCRF) and associated applications and customization of relevant image viewing/analysis tools
- Conduct User Acceptance Testing
Participate in Independent Reviewer Selection
- Review CVs of potential independent reviewers.
Prepare and conduct Independent Reviewer Trainings
With minimal 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
Independent Reviewer Performance Monitoring
- With minimal supervision - 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 contribute to project related client meetings
Communication
- Effective and professional communication with internal and external stakeholders; acts 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.
Functional Competencies (Technical knowledge/Skills)
- Ability to perform the assigned tasks with minimal supervision
- 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
- A self-starter and able to work under own initiative
Behaviour Competencies
- Accountability
- Adaptability
- Customer focus
- Decision Making
- Quality focus
- Attention to detail
- Teamwork
- Time management
Experience Education and Certifications
- 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.
- MD/PhD or MS/MA RPh with considerable experience or BA/BS/RN/BSN/Technologist Certification with substantial experience in imaging or clinical trials
- English: Fluent
Come as you are.
Were 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.