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:
HEALTH:
- Medical plan for you and your dependents.
- Personal Accident Insurance
- Life Insurance
- Critical illness cover
WEALTH:
- Salary structure and Flexi basket
- Provident fund of 12%
- Gratuity scheme
YOURSELF: Internal growth and development programs & trainings
Job Summary:
As a 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 lead all on project related aspects of documents, application development with supervision. Furthermore, 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.
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 supervision – 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
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.
- 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 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 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 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 project related client meetings
Communication
- 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.
Functional Competencies (Technical knowledge/Skills)
- 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
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.
- MS/MA, RPh with experience or BA/BS/RN/BSN/Technologist Certification with experience in imaging or clinical trials
- English: Fluent
Come as you are.
We're proud to be a Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, 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.
