Chris Poulos
Clinical Project Lifecycle Experience [Project Launch] represented clinical operations at sales presentation for new business opportunities; reviewed scope... | Atlanta, Georgia, United States
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Chris Poulos’s Emails ch****@qu****.com
Chris Poulos’s Phone Numbers No phone number available.
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Chris Poulos’s Location Atlanta, Georgia, United States
Chris Poulos’s Expertise Clinical Project Lifecycle Experience [Project Launch] represented clinical operations at sales presentation for new business opportunities; reviewed scope of work and provided input to sales/proposal team; performed resourcing analysis to provide input for budget and CRA needs; protocol and amendment review and development; site feasibility assessments; selection of investigators; initial and ongoing regulatory document review; developed materials and presented at investigator meetings [Project Management] managed multi-million dollar clinical budgets; development of clinical change orders; attended meetings with key sponsor and internal personnel; worked closely with vendors to ensure project success; developed meeting agendas/minutes [Clinical Management] created clinical monitoring plans; trained and managed CRAs and Clinical Assistants; developed source data verification plans; created source documents for sites; resolved site issues; provided performance feedback for team members; mentored CRAs during their career progression; auditing, quality control , and transfer of Trial Master Files to Sponsor; reviewed 1000+ monitoring visit reports [Monitoring] 500+ monitoring visits with 650+ days on-site; source data verification; Informed Consent review; drug accountability and relabeling; Investigator Site File review; Electronic Data Capture (Inform and Medidata); remote data review; query generation and resolution; site staff training [Data Management] developed CRF completion guidelines; created and reviewed eDC edit specs; reconciled external databases with clinical database; 12 successful, on-time database locks [Quality Assurance / Regulatory] Barnett GCP certified 2012/2014; learned and followed sponsor and internal SOPs; assisted sites/sponsors with internal, sponsor, and FDA inspections; intensive audits of central clinical file and investigator site files; responded to site audits; developed and implemented correction action plans for sites
Chris Poulos’s Current Industry Eli Lilly
Chris
Poulos’s Prior Industry
Quintiles
|
Eli Lilly
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Work Experience
Eli Lilly
Clinical Development Consultant
Wed Apr 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Quintiles
Clinical Trial Leader / Clinical Study Manager
Mon Apr 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Apr 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Chris Poulos Email Addresses
FAQ About Chris Poulos
-
Chris Poulos is located at
Atlanta, Georgia, United States -
Chris Poulos is a
Clinical Project Lifecycle Experience [Project Launch] represented clinical operations at sales presentation for new business opportunities; reviewed scope of work and provided input to sales/proposal team; performed resourcing analysis to provide input for budget and CRA needs; protocol and amendment review and development; site feasibility assessments; selection of investigators; initial and ongoing regulatory document review; developed materials and presented at investigator meetings [Project Management] managed multi-million dollar clinical budgets; development of clinical change orders; attended meetings with key sponsor and internal personnel; worked closely with vendors to ensure project success; developed meeting agendas/minutes [Clinical Management] created clinical monitoring plans; trained and managed CRAs and Clinical Assistants; developed source data verification plans; created source documents for sites; resolved site issues; provided performance feedback for team members; mentored CRAs during their career progression; auditing, quality control , and transfer of Trial Master Files to Sponsor; reviewed 1000+ monitoring visit reports [Monitoring] 500+ monitoring visits with 650+ days on-site; source data verification; Informed Consent review; drug accountability and relabeling; Investigator Site File review; Electronic Data Capture (Inform and Medidata); remote data review; query generation and resolution; site staff training [Data Management] developed CRF completion guidelines; created and reviewed eDC edit specs; reconciled external databases with clinical database; 12 successful, on-time database locks [Quality Assurance / Regulatory] Barnett GCP certified 2012/2014; learned and followed sponsor and internal SOPs; assisted sites/sponsors with internal, sponsor, and FDA inspections; intensive audits of central clinical file and investigator site files; responded to site audits; developed and implemented correction action plans for sites Eli Lilly -
Chris Poulos currently works in the
Eli Lilly -
Chris Poulos specializes in
Clinical Project Lifecycle Experience [Project Launch] represented clinical operations at sales presentation for new business opportunities; reviewed scope of work and provided input to sales/proposal team; performed resourcing analysis to provide input for budget and CRA needs; protocol and amendment review and development; site feasibility assessments; selection of investigators; initial and ongoing regulatory document review; developed materials and presented at investigator meetings [Project Management] managed multi-million dollar clinical budgets; development of clinical change orders; attended meetings with key sponsor and internal personnel; worked closely with vendors to ensure project success; developed meeting agendas/minutes [Clinical Management] created clinical monitoring plans; trained and managed CRAs and Clinical Assistants; developed source data verification plans; created source documents for sites; resolved site issues; provided performance feedback for team members; mentored CRAs during their career progression; auditing, quality control , and transfer of Trial Master Files to Sponsor; reviewed 1000+ monitoring visit reports [Monitoring] 500+ monitoring visits with 650+ days on-site; source data verification; Informed Consent review; drug accountability and relabeling; Investigator Site File review; Electronic Data Capture (Inform and Medidata); remote data review; query generation and resolution; site staff training [Data Management] developed CRF completion guidelines; created and reviewed eDC edit specs; reconciled external databases with clinical database; 12 successful, on-time database locks [Quality Assurance / Regulatory] Barnett GCP certified 2012/2014; learned and followed sponsor and internal SOPs; assisted sites/sponsors with internal, sponsor, and FDA inspections; intensive audits of central clinical file and investigator site files; responded to site audits; developed and implemented correction action plans for sites -
Chris Poulos speaks the following languages:
No languages available. -
Chris Poulos has prior experience in the following industries:
Quintiles -
Chris Poulos has the following professional experience:
Eli Lilly , Quintiles . -
You can view Chris Poulos’s
LinkedIn profile at LinkedIn URL. -
Chris Poulos’s work email addresses are
[email protected] . -
Chris Poulos works at
Eli Lilly
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