PAULINE DELANEY

Cincinnati, Ohio area

(859) 750-1099, paulinedelaney33@gmail.com
LinkedIn profile: http://www.linkedin.com/in/paulinedelaneycdm
PROFESSIONAL SUMMARY
Extensive project experience on global clinical trials in a clinical research organization (CRO) in the
pharmaceutical industry; three years in IVRS project management and seven years in clinical data management
(CDM). Medical sales; presenting and training at all levels.
ACCOMPLISHMENTS

Achieved cost savings to employer of $80,000 by co-developing a rate illustration program

Developed on-site sales training program for six-person outbound/inbound sales/service center leading
department to 90% growth in new product sales during a nine-month period
Sold, trained, and implemented medical records system in hospitals/clinics state-wide

EXPERIENCE
INC Research Holdings
Global Clinical Research Organization

IVRS Project Manager

2012 2015
Lead global clinical IVRS projects, including vendor management and drug supply/investigational
product management
Manage requirements gathering, specifications, quality review, and user acceptance testing (UAT)
Work with biostatistics, ensure subjects randomize according to requirements, and integrity of blinded
systems, reports, and security of user roles are maintained
Produce high-quality deliverables through careful planning, testing and QA efforts
Manage changes in accordance with FDA regulations in rapidly evolving global environment
INC Research, LLC (through acquisition of Kendle International Inc.)
Senior Clinical Data Associate (CDA)
2011 2012
Four years as team lead managing workload of 16 CDAs
Mentored and cross-trained team on project specific and general CDM processes
Oversight of database cleaning activities: receipt and pre-entry preparation of case report forms (CRF),
data entry, data review, query generation and resolution, and data reconciliation
Estimated project hours and resourcing needs
Communicated expectations and milestones to stakeholders to ensure deliverables met schedule,
budget, and produced clean data
Developed alternative processes to improve quality or speed of deliverables
Provided oversight of serious adverse event (SAE) reconciliation, and investigator site payment process
Led meetings with study center personnel, sponsor, affiliates, and internal departments
Developed ad hoc project reports and metrics
Contributed to development and maintenance of study documentation ensuring documents reflected
project assumptions and scope of contracted work

Delaney, Pauline
Kendle International Inc.
Clinical Data Associate II (began as CDA I, promoted to CDA II)
2005 2011
Performed complex case report form (CRF/eCRF) data review as well as CRF tracking, validation and
updating of database; SAE and laboratory data reconciliation
Developed understanding of standard operating procedures (SOP), regulatory directives, and study
plans and guidelines
Supported CRF database testing and external vendor data reconciliations
Reviewed and generated ad hoc listings, reports, and quality control documentation to facilitate
validation of clinical databases
Provided accurate, timely, and consistent data to sponsors and management
Updated multiple systems and resolved data discrepancies by applying study conventions
Liaised with sponsors, research sites, clinical programming, safety, and finance departments
PREVIOUS EXPERIENCE
Great American Life Insurance Company, Senior Marketing Specialist; Technical Sales Coordinator, Agent
Automation Worksite Division
Inland Diamond Products, Optical Supplies and Equipment, Sales Manager Retail Division
Hollister, Inc., Medical Disposables, Territory Manager
EDUCATION
Thomas More College, Crestview Hills, KY
Bachelor of Arts in Business Administration
Graduation:
2005 GPA: 3.8/4
OTHER SKILLS
Clinical Database Experience: Inform; Medidata/RAVE/Balance; ClinPhone; TOAD; Q&E: TrialWeb; multiple
vendor systems and proprietary databases, International Conference on Harmonization (ICH) and Good Clinical
Practice (GCP), 21 CFR Part 11
Computer Skills: Microsoft Office: Word, Excel, PowerPoint, Outlook, OneNote, Lotus Notes, and Internet
research
Languages: Conversational Japanese