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
Key Responsibilities
Technical Governance
- Establishes and owns the governance framework for imaging application configuration, validation, technical documentation and workflow design.
- Acts as the final technical authority for complex imaging application decisions, escalations and exceptions within defined scope.
- Ensures consistent, compliant and scalable technical execution across imaging delivery.
- Accountable for improving scalability, technical consistency, quality and inspection readiness across imaging application delivery.
Imaging Application Standards and Framework
- Own and lead the design of technical solutions to collect data required for clinical trial endpoint evaluation as described in the Imaging Review Charter.
- Own the standards, governance model and technical quality framework for Trial Configuration Specifications, ensuring consistency, scalability, compliance and adoption across imaging application delivery.
- Lead initiatives for developing imaging read/analysis system configurations at the project level.
- Lead and oversee cross-functional reviews of technical documentation and specifications, ensuring alignment with project requirements, operational considerations, and Medical Writing expectations.
- Identify and lead departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, central content standards, and scalable documentation and workflow frameworks.
- Define and lead process optimization initiatives with Image Management to develop more efficient processes to manage data movement.
- Identify, evaluate and communicate potential risks related to deliverables as well as their mitigation.
- Provide strategic direction and technical requirements for electronic case report form design to ensure alignment with imaging review workflows and data capture standards.
- Define and oversee test data requirements to support data transfer agreement development and ensure technical readiness for downstream data management activities.
Stakeholder Relationship Management
- Serve as the medical writing imaging applications lead on assigned project teams, communicate content requirements, define technical expectations, lead/facilitate authoring team meetings to drive cross-functional alignment.
- Serve as a primary client contact for technical configuration and specification document projects, negotiating deliverable timelines and resolving project related issues.
- Set strategic direction and provide subject matter expertise for the evaluation of new and novel imaging platforms, applications and services for imaging viewing and processing.
- Train independent reviewers on imaging applications, when needed.
Quality management
- Lead quality-focused process improvements with Image Management, including the implementation of programmatic system tools to enhance preliminary QC efforts and movement of data (e.g. PowerShell Scripts).
- Lead user acceptance testing (UAT) development of imaging read/analysis system configurations at the project level.
- Support the Image Analysis and QC groups with escalated workflow QC and query activities, as needed
Other
- Carryout any other reasonable duties as requested.
Functional Competencies (Technical knowledge/Skills)
- Expert knowledge of imaging application architecture, configuration governance, BICR workflows, DICOM/data transfer standards and regulated clinical imaging delivery.
- Ability to define business wide standards and technical control frameworks across multiple imaging platforms.
- Advanced judgement in balancing scientific, operational, client and technology requirements.
- Ability to influence senior stakeholders and resolve complex technical trade-offs.
- Excellent interpersonal, verbal and written communication skills.
- Demonstrable knowledge of industry guidelines and regulations, i.e., ICH-GCP.
- Ability to consistently produce technical documents of high quality with proven ability of using Microsoft Office products (including Word, Excel & PowerPoint).
- 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 identify and implement process improvements.
- Proactively participates in skills improvement training and encourages their teams to participate.
- Ability to coach others to succeed; sharing knowledge, skills, and expertise to others.
- Builds and maintains an in-depth knowledge of technology within the life sciences industry and how it affects customers adopting our products.
Behaviour Competencies
- Accountability
- Adaptability
- Customer focus
- Cross-functional collaboration
- Decision Making
- Analytical thinking
- Results orientation
- Building effective teams
Experience, Education, and Certifications
- Significant demonstrable experience acting as a senior technical authority within clinical imaging, imaging applications, BICR workflow design or regulated clinical trial technology environments.
- Solid proven experience of working in and knowledge of medical imaging or clinical development in the life sciences industry.
- Experience working effectively in a fast paced, matrix managed, multi-disciplinary environment with cross-functional teams.
- Proven experience defining technical standards and/or governance frameworks across multiple studies, clients or platforms.
- Experience troubleshooting medical image related issues, especially DICOM.
- Experience with Multimodality Clinical Imaging Standard Practices.
- Experience with Imaging Read Criteria’s (e.g. RECIST 1.1, PCWG3, Lugano, etc.).
- Medical Writing experience, preferred.
- Experience with MINT and MIM applications, desirable.
- Bachelor's Degree in a technical discipline (Medical degree/ PhD) or a related study, or equivalent project-related experience.
- Masters, desirable.
- Certifications in 1 or more of the following: CNMT, RT(N)(CT)(MR), preferred.
- 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.
