VERONICA PURA
Dickinson,TX
Summary
Self-motivated professional experienced in clinical outcome assessments, quality assurance, and vendor management in deadline-driven environments. Effective and organized with drive for fostering interdepartmental collaboration and overall efficiency.
Overview
10
10
years of professional experience
Work History
Clinical Outcomes Assessments (Vendor) Manager
Cogstate
Remote
08.2021 - Current
- Manages production and distribution of clinical outcome assessments for global sites
- Leads projects as a clinical assessment lead for CNS (Alzheimer’s, dementia, depression) and pediatric rare disease trials
- Oversees procurement and logistics of materials for clinical trial studies
- Collaborates with sponsors, operational team, and logistics providers to ensure that sites are SIV ready
- Participates in RFPs and budget inputs for change orders
- Conducts financial study reconciliation of materials and licenses used in clinical trial studies
- Participates in the identification and review of suppliers/vendors
- Monitors vendor quality, and maintains a current database of vendor information
- Supervise and develop junior staff
- Cross-trained on project management, rater training, and learning management functions
- Identified opportunities to improve operational practices, devised strategies and implemented plans to increase quality of delivery to sponsor and clinical sites.
Associate Clinical Outcomes Assessment Manager
Cogstate
New Haven, CT
04.2018 - 08.2021
- Create and maintain scales databases and libraries and project tracking tools
- Oversees production of study specific source documents for submission to IRB and sponsor
- Leads projects as a clinical assessment lead for CNS (Alzheimer’s, Parkinson's, dementia, depression) and pediatric rare disease trials
- Proposal and project development support
- Use of agile technologies for reporting and tracking
- Create and maintain scales databases and libraries and project tracking tools
Quality Assurance Specialist
Par Pharmaceuticals
Stratford, CT
11.2017 - 02.2018
- Monitored the circulation and archival of controlled documents in compliance with GMP and ISO
- Created and reviewed logbooks, SOPs, Change Controls, Methods, and Batch Records for generic drugs and wound recovery medical device
- Assisted in implementation and administration of electronic quality management system (CPro)
- Performed internal audits of the facility for FDA, ISO, and DEA compliance.
Quality Assurance Auditor at Bayer CropScience
Knoell
Durham, NC
09.2015 - 10.2017
- Monitored compliance of laboratories and facilities through audits and quality assurance review of reports for agricultural and chemical studies
- Ensured audit readiness of US and Canada studies
- Determined priorities to meet deadlines using project management
- Supervised and trained Knoell new hires at client site
- Recognized by client with Service Award February 2017 (embedded employee at Bayer).
Associate Scientist/Reviewer
Catalent Pharma Solutions
Morrisville, NC
06.2014 - 09.2015
- Created a metric to measure turn around time and cost based on report quality and utilized MiniTab for statistical analysis of data
- Managed forecasting spreadsheets to present upcoming weekly projects and revenue to project directors
- Championed safety initiatives through audits and creation of JSAs
Bioprocess Technician
Merck
11.2012 - 05.2014
- Initiated a process improvement project to increase efficiency of sample freezing time
- Participated in safety and waste audits, lean six-sigma methodologies in quality and safety training
- Served as assistant documentation controller and batch record reviewer
- Authored SOPs for technical processes used in purification/sonication/filtration of virus cultures
Education
Master of Science - Project Management
University of Wisconsin
Platteville, WI08.2022
Bachelor of Science - Biochemistry
North Carolina State University
Raleigh, NC05.2012
Skills
- Auditing
- GxP (GLP, GMP, GCP)
- Vendor Management
- Quality Assurance auditing
- Agile reporting software (JIRA)
- ERP systems (SAP)
Timeline
Clinical Outcomes Assessments (Vendor) Manager
Cogstate
08.2021 - Current
Associate Clinical Outcomes Assessment Manager
Cogstate
04.2018 - 08.2021
Quality Assurance Specialist
Par Pharmaceuticals
11.2017 - 02.2018
Quality Assurance Auditor at Bayer CropScience
Knoell
09.2015 - 10.2017
Associate Scientist/Reviewer
Catalent Pharma Solutions
06.2014 - 09.2015
Bioprocess Technician
Merck
11.2012 - 05.2014
Master of Science - Project Management
University of Wisconsin
Bachelor of Science - Biochemistry
North Carolina State University