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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in analyzing clinical trial documentation and translating scientific requirements into functional specifications. Proficient in collaborating with multidisciplinary teams to support software implementation, validation, and project management in regulated healthcare environments.
Highest-signal resume keywords
Clinical Trial ProcessesSoftware Requirements DevelopmentMedical Imaging ExperienceProject Coordination SkillsAnalytical Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Software Configuration SpecificationsUser StoriesWorkflow DocumentationFunctional SpecificationsData MappingData Transfer FormatsSoftware ValidationUser Acceptance TestingClinical Research OperationsRegulated Healthcare Environments
Soft Skills
Strong Problem-Solving SkillsAttention to DetailExcellent Verbal CommunicationExcellent Written CommunicationOrganizational Skills
Tools & Technologies
Microsoft OfficeWordExcelPowerPointOutlook
Industry Keywords
Clinical ResearchMedical Imaging TechnologiesClinical Data ManagementSOPsQRGs
About the role
Key responsibilities & impact- Analyze clinical trial documentation, including protocols, imaging charters, procedure manuals, compliance reports, and related study materials, to define software requirements
- Partner with Medical Imaging business stakeholders to understand operational workflows, scientific requirements, and technology needs
- Translate scientific, clinical, and therapeutic requirements into functional and configuration specifications
- Gather, document, maintain, and manage study-specific requirements for internal and external software products and services
- Facilitate requirement reviews with scientific teams, project teams, configuration teams, developers, and other stakeholders
- Develop documentation supporting software configuration and implementation
- Create and distribute project reports, requirement documentation, and stakeholder communications
- Identify risks, dependencies, and impacts related to software configuration and delivery, escalating concerns when appropriate
- Provide guidance to Development and Validation teams regarding study requirements and system behavior
- Support software validation, user acceptance testing, deployment activities, and issue resolution
- Collaborate with teams to investigate software defects, system issues, and support tickets
- Partner with Medical & Scientific Affairs teams to align study documentation with software functionality and operational requirements
- Support Product Management with input for enhancements, new features, product improvements, and future technology needs
- Participate in study kick-off meetings and collaborate with Project Management on timelines, scope changes, and delivery expectations
- Support Clinical Data Management teams by aligning data capture, database structures, data transfers, and software configurations
- Provide guidance on data mapping, data transfer formats, and reporting requirements
- Contribute to SOPs, QRGs, work instructions, and process documentation
- Stay informed on industry trends, medical imaging technologies, clinical research processes, and software advancements
Requirements
What you’ll need- Bachelor's degree in Life Sciences, Computer Science, Healthcare, Information Technology, Biomedical Sciences, Clinical Research, or a related field required, or equivalent combination of experience and education
- Minimum 2 years of experience as a Clinical Business Analyst, Medical Writer, Clinical Data Management professional, Project Manager, or similar role supporting clinical research technologies
- Experience working collaboratively across business stakeholders, technology teams, and customers in a global environment
- Understanding of clinical trial processes, clinical research operations, and regulated healthcare environments preferred
- Medical imaging experience is highly desirable
- Experience developing software requirements, configuration specifications, user stories, workflow documentation, or functional specifications preferred
- Strong analytical skills with the ability to understand and communicate complex scientific and technical concepts
- Experience supporting software implementation, validation, testing, or deployment activities
- Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook
- Strong organizational and project coordination skills with the ability to manage multiple priorities and deadlines
- Excellent verbal and written communication skills with the ability to communicate effectively in English
- Strong problem-solving skills, attention to detail, and commitment to quality
- Ability to work independently while collaborating effectively across multidisciplinary teams
- Professional, proactive, and customer-focused mindset with a passion for continuous improvement
Benefits
Comp & perks- Competitive pay and incentives
- Provident fund and medical insurance
- Engaging employee programs and local events
- Modern office spaces and remote work flexibility
