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.