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
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
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
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
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
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
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