Clinical Data Manager – Digital Medicine and Translational Imaging
Parexel
full-time
Posted on:
Location Type: Remote
Location: United States
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About the role
- Data Management POC for studies in which we are included in
- Responsible for mapping local study dictionaries to CDISC Standards
- Participate and contribute to the development of operational plans to ensure data quality and completeness
- Develop, Implement, and Conduct data quality checks as needed for work/studies
- Work closely with the various stakeholders to understand evolving project portfolio needs, and integration into the systems and requirements; supporting studies with a wide range of disease domains
- Contribute technical expertise toward the design, implementation, and scaling up of sensor systems and analytics
- As a medical informaticist, ensure collection, organization, curation, storage and safeguarding of patient data from lab, asset teams, and external collaboration studies is consistent with 21CFR part 11
- Contribute to the overall architecture of the existing data pipelines and workflows, recommends and implements improvements
- Track emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality
- Manage own time to meet agreed targets
- Work under general supervision. Performs assignments using established procedures and general instruction
- Share learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications
Requirements
- Master's degree in Health Informatics, Computer Science, Information Systems, or similar field required
- A minimum of 5+ years of technical experience required, including: Python, Unix/Linux environments, Version control systems (ex. Git), AWS or other cloud-based development, Electronic data captures (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Rave
- Familiarity with pharmaceutical informatics standards like CDISC and MedDRA
- GCP experience
- Strong interpersonal and collaboration skills
- Demonstrate the ability to build consensus and be agile to changing circumstances and priorities
- Hands-on experience with Clinical Data Management, including Case Report Form (CRF) design, CRF annotation, database design, data collection, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, and regulatory requirements
Benefits
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
PythonUnix/LinuxVersion control systemsAWSElectronic data captureClinical Data ManagementCase Report Form designData validationMedical codingDatabase design
Soft Skills
Interpersonal skillsCollaboration skillsConsensus buildingAgilityTime management
Certifications
Master's degree in Health InformaticsMaster's degree in Computer ScienceMaster's degree in Information Systems