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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Data Monitoring and Management (DMM) activities, ensuring high-quality database design and adherence to regulatory requirements. Proficient in Clinical Trial Management Systems (CTMS) and electronic documentation management, with strong communication and problem-solving skills.
Highest-signal resume keywords
Data Monitoring And ManagementClinical Trial Management Systems (CTMS)ICH/GCP Documentation RequirementsElectronic Documentation Management SystemsGood Clinical Practice Principles
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data ReviewQuery ManagementData ValidationQuality Control ProcessesRegulatory RequirementsMicrosoft Office SuiteClinical Data Collection ToolsProcess ImprovementAttention To DetailProblem-Solving
Soft Skills
Strong Oral CommunicationStrong Written CommunicationCollaborative Teamwork
Tools & Technologies
Electronic Documentation Management SystemsWeb-Based Data Management SystemsAI ToolsGenerative TechnologiesMicrosoft Copilot
Industry Keywords
Standard Operating Procedures (SOPs)Clinical Development ProcessTrial Master File (TMF)Responsible AI PracticesRisk Management
About the role
Key responsibilities & impact- Engage in Data Monitoring and Management (DMM) activities, including data review, query management, and investigating logic check flags
- Ensure database design quality through documentation, testing, validation, and implementation of clinical data collection tools or systems
- Serve as the first point of contact for customers needing assistance with Clinical Trial Management System (CTMS) questions and issues
- Adhere to applicable Standard Operating Procedures (SOPs) and working practices
- Collaborate with Study Team Points of Contact, Document Owners, and Trial Master File (TMF) Study Owners to resolve document-related discrepancies and issues
- Contribute to process improvement initiatives and additional projects as they arise
Requirements
What you’ll need- BA/BS with any years of experience
- Demonstrated experience of ICH/GCP documentation requirements
- Hands-on experience with electronic documentation management systems and/or web-based data management systems
- Awareness of the clinical development process, including a deep understanding of Good Clinical Practice principles
- Solid grasp of regulatory requirements and relevant data standards
- Strong oral and written English communication skills
- Proficiency in Microsoft Office Suite
- Experience with clinical trial management systems (CTMS) preferred
- Familiarity with data validation and quality control processes preferred
- Ability to work collaboratively in a team environment preferred
- Strong problem-solving skills and attention to detail preferred
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, preferred
- Understanding of responsible AI practices, including risk management and ethical use, preferred
- CV must be submitted in English
Benefits
Comp & perks- Hybrid work arrangement
- Flexible workplace culture supporting work-life harmony
- Reasonable adjustments and disability inclusion support
- Equal employment opportunities
- Accessibility assistance for the application and interview process
