Michele Galvin
Manager, Clinical Data Acquisition, External Vendor Data, Portfolio Lead: Dermatology, Rheumatology, Rare Disease
- Role
- Manager, Data Acquisition - External Vendor Data at Johnson & Johnson Innovative Medicine
- Location
- Chester Springs, PA, US
- LinkedIn followers
- 500 followers
About Michele Galvin
I have experience in a wide variety of Pharmaceutical business applications including external/eSource data oversight, Database Design and Build, Vendor oversight/Management/procurement, Database Standardization using CDISC/SDTM modeling, Electronic Data capture (eDC), Laboratory data oversight, therapeutic area program oversight for data management and onboarding/mentoring of new data management personnel. I also have experience in data quality oversight, streamlining and standardization as well as TMF structure/compliance (Veeva, Documentum,etc) as team VTMF champion.My current area of focus is immunology clinical trials for external data vendor oversight and ePRO/eCOA SME Team Lead
Experience
Manager, Data Acquisition - External Vendor Data
Johnson & Johnson Innovative Medicine
May 2021 — Present · Springhouse, PA, US
Education
Temple University
Bachelor of Science Degree, Clinical Laboratory Science
1985 — 1989
Skills
- Troubleshooting
- Microsoft Office
- Database Design
- Central Designer/Inform
- Gcp
- Pharmaceutical Industry
- Sop
- Data Management
- Edesigner/Crf Design
- Edc
- Therapeutic Areas
- Ctms
- Validation
- Ich-Gcp
- Medidata Rave
- Biotechnology
- Outsourcing Management
- Clinical Data Management
- Good Clinical Practice (Gcp)
- Oracle Clinical
- Vendor Management
- Clinical Laboratory Management
- Clinical Trials
- Clinical Trial Management System (Ctms)
- CRO
- 21 Cfr Part 11
- Data Standards
- Oncology
- Protocol
- Clinical Study Design
- Electronic Data Capture (Edc)
- Project Management
- CRO Management
- Adobe Framemaker
- Cdisc
- Clinical Research
- Clinical Development
- Sdtm
- Vendor Relationship Management
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