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Biotechnology Data Analyst
60 Temple St #8a New Haven, CT 06473
Biotechnology Data Analyst
- Build data conversion paths and develop efficient sponsor deliverable file formats, including CDISC SDTM and ODM compliance requirements
- Design and develop custom calculations, error checks, and automated data validation routines.
- Develop data collection forms to maximize efficiencies in data acquisition across multiple imaging modalities and therapeutic areas.
- Provide internal Core Lab data analytics support to study teams
- Utilize analytic tools to program/generate summarizes of study data to support study teams
- Identify requirements and create customized reports from Core Lab systems
- Assist with the development of data integrations for continuity across internal data platforms
- Participate in software user requirement definitions and updates, representing comprehensive data management from data acquisition through the data reporting study lifecycle.
- Uses database quality standards including the oversight of standard eCRF library and version control processes.
- Bachelor’ s Degree technology or computer science preferred
- Experience implementing CDISC standards
- Strong understanding of GxP
- Advanced with 21 CFR Part 11
- SAS programming experience
- Experience with EDC (e.g. Open Clinica, RAVE, Inform, TrialMaster, etc.)
- Advanced SQL proficiency
- 5+ years’ experience in Data Analytics
- Healthcare, Biotech or similar industry knowledge preferred
- Working knowledge of FDA Guidance Documents / EU Directives.
- Experience working with clinical development support.
- Experience with Alfresco software
- Additional languages Visual Basic, C#, Pearl, Python a plus
- Preferred experience using XML and JSON code
Location -New Haven County
Send resume to KrishaM@JMorrissey.com
Director, Healthcare Services & Healthcare IT
Krisha Morander, a Certified Personnel Consultant, (CPC), has over 25 years of experience in the healthcare staffing industry. She also has corporate HR Recruitment, homecare, mental health and academia background to compliment her overall knowledge of hiring talent. Krisha has been continually recognized within our agency for achieving record-high placement activity.
She places all levels of healthcare professionals within a broad spectrum of healthcare organizations across Connecticut and Massachusetts including hospitals, managed care organizations, physician practices, pharmaceutical organizations, mental health, government facilities, and long term care and rehab facilities.
Krisha also complements her searches in the areas of clinical recruitment, information technology and clinical trials & research. The blend of clinical informatics, statistics and analysis are an integrated part of measuring outcomes and data to measure surveys and scores. Krisha continues to stay connected with this evolving and complex industry through her membership with the New England Chapter of Healthcare Information and Management Systems Society (HIMSS).
Krisha majored in marketing with a concentration in Human Resources. Krisha’s industry knowledge, communication skills and passion for recruiting make her an invaluable recruiter here at J. Morrissey.