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
Responsibility
Supporting Activities
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.
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.
Skills Required
- Ability to author internal and external clinical imaging documents (image acquisition guidelines, QC forms)
- Experience reviewing project plans, site operations manuals, reviewer manuals, and clinical data transfer instructions
- Experience creating and delivering training materials for sites, CRAs, clients, and internal teams
- Familiarity with image viewing/analysis tools and supporting application requirement review and User Acceptance Testing
- Experience selecting, training, and monitoring independent reviewers and performing reviewer QC
- Quality and compliance skills: identify non-compliances, review audit findings, and drive corrective actions
- Strong professional communication skills with internal and external stakeholders
What We Do
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. Perceptive’s offerings include imaging biomarkers and core lab services, as well as innovative technologies in randomization and trial supply management (RTSM), analytics, and software.
