Curriculum Vital

TargetCW  
November 2018 – Current

SR Consultant – Program / Project Management – Life Sciences

  • Creation and oversight of data demand and release SharePoint site to request data extracts for four key phase three projects. 

  • Development and management of cross-organizational processes and reviews for key TLF's (Table, Listing and Figures).

  • Oversight of multiple eTMF migrations, including creation of SOW’s and CRO and TMF vendor management.

  • Managing the implementation of a SaaS based eTMF solution.

  • Creation of an eClinical solution.

  • Additional SaaS solutions for management of the full clinical trial lifecycle.   

  • Management of the selection process for a single Argus Safety Database, including a FSP agreement and the migration of two current databases.

  • FDA Inspection Readiness and mock audits

 

Instant Technology
January 2017 – December 2018

SR Consultant – Program / Project Management – Life Sciences

  • Implementation of a SaaS based EHS Material Compliance system, including supplier and manufacturing data from both JDE and SAP.

  • Implementation of an Operational Contractor Environmental, Health & Safety Pre-Qualification and Vetting System (CEPVS) utilizing a SaaS based system.

  • Aiding in the enhancement of program and project management tools.

 Abbvie Pharmaceutical (Abbott 12/12)
December 2012 – December 2016

SR IT Project Manager / Program Manager – Life Sciences

  • Clinical Trial Master System Replacement Phase 0.

  • eTMF (Electronic Trail Master File system) for clinical trials.

  • Program level management for a multimillion-dollar eClincal strategy.

  • Clinical Trials visit reports and Clinical Trials government website posting documents (Clinical Trials.gov.)

  • Portals for Therapeutic areas for internal and external data collection.

  • Participate in PMO Project Management Excellence Committees and PMO process improvements.

  • Program Manager for Clinical Operations, (>$5MM portfolio) / IT Internal Projects ($2MM portfolio), which included all of IT infrastructure and SharePoint projects; this included all financial management and reporting, overall assessment of priorities within the portfolio and oversight of the project managers managing the projects.

 

RCG Information Technology 
October 2010 – December 2012

SR Project Manager – Consultant (Major industry – Pharmaceutical) – Life Sciences

  • A system to track Subject and Deviation issues for clinical trials .

  • A reporting system for Clinical Research Analyst onsite visits to drug trial sites.

  • Two Disaster Recovery Environment set ups and testing initiatives.

For full Curriculum Vital please contact me and for more details please visit my LS Program / Project Summary page.