John V. Mitchell
- Role
- Clinical Data Scientist (Manager) at 辉瑞
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About John V. Mitchell
I am an experienced Clinical Data Management professional who has worked in the industry…
Experience
Clinical Data Scientist (Manager)
Jan 2020 — Present
Responsibile for all DM & M activities including selection and application of data acquisition standards, Data Management Plan, selection of quality risk indicators, third party study data due diligence · Participates and ensures quality database design including documentation, testing and implementation of clinical data collection tools, both CRF and non-CRF, using an electronic data capture (EDC) system and/or other data collection systems. · Serve as a technical resource to the study teams for DM and RBM standards, tools, data provisioning, and reporting · Partners with Research/Business Units and any external DM service provider to deliver high quality data management for all studies as assigned. · Proactively drives quality and efficiency to meet timeline and milestones for data management, ensuring scientific and operational excellence in support of strategic imperatives and in collaboration with the cross functional study team (s). · Ensure work carried out by DM providers is in accordance with applicable SOPs and working practices. · Ensure the required study-specific DM & M documents in the Trial Master File (TMF) are of high quality and are filed contemporaneously. · Ensure operational excellence in collaboration with partners for application of standards, data acquisition, proactive data review and data integrity monitoring, data cleaning, e-data processing, data access and visualization, and database release.
Education
Temple University
BS - Computer Enginerring, Computer Engineering
2005 — 2013
Skills
- Medidata
- Fda
- Inform
- Validation
- Clinical Research
- Oncology
- Good Clinical Practice (Gcp)
- Clinical Trials
- Pharmaceutical Industry
- Html
- Windows
- Management
- Clinical Data Management
- Ich-Gcp
- Cdisc
- Excel
- Crf Design
- Data Management
- Regulatory Affairs
- Biotechnology
- Electronic Data Capture (Edc)
- Databases
- Therapeutic Areas
- CRO Management
- CRO
- Microsoft Office
- Customer Service
- Protocol
- Microsoft Excel
- Edc
- Clinical Development
- Documentation
- Sop
- 21 Cfr Part 11
- Gcp
- Ctms
- Oracle Clinical
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.