Gina R DiGulielmo CV October 2016

GINA R. DIGUGLIELMO Long Valley, NJ | 862.452.1949 | ginadiguglielmo@comcast.net
CAREER HIGHLIGHTS
 Managed budgets of up to $10MM and trials of up to 1,300 Pts.
 Developed R&D training content utilized by thousands of individuals across US, Europe, and Emerging Markets.
 Lead Process Improvement Initiatives that reduced time by 50% and resourcing costs by 30%.
 Business Leader on initiatives that increased user productivity by 25% and compliance to regulators by 80%.
 Developed training content for off-shoring, and global clinical operations across 20 countries.
EXPERIENCE
Pharmaceutical & Healthcare Consultants Inc., Long Valley, NJ
Owner / Independent Consultant
March 2011 – Present
• Independent Clinical Research Consultant for Pharmaceutical, Biotech, Device, Consumer, and Clinical Research
Organizations (CROs); specializing in Clinical Research Operations and Project Management.
• Managed 5 direct reports and budgets of up to $1MM for studies of up to 400 participants.
• Execute short and long term assignment in areas of clinical development and clinical operations.
• Expertise: Project management, trial recruitment, budget management, trial metrics, training, vendor management,
process improvement initiatives, Key Opinion Leader (KOL) development
Novartis Pharmaceuticals, East Hanover, NJ
May 2004 – February 2011
Novartis Global Clinical Development & Medical Affairs Drug Safety & Epidemiology
Associate Director Medical Safety Operations
November 2009 – February 2011
• Served as Project leader on process improvement projects for clinical drug safety operations; reduced resourcing
costs by 30% and time by 50% while increasing user productivity by 25% and compliance to regulators by 80%.
• Managed global cross functional teams of 2-20.
• Led off-shoring activities for all products requiring ASR/DSUR; approximately 80 compounds.
• Developed and conducted training programs for medical safety staff and other relevant line functions within Clinical
Development and Novartis Pharma worldwide; trained groups of 200+.
• Designed roll-out strategies, training, and corporate communications on project initiatives reaching thousands of R&D
employees in 16 countries.
• Identified regulatory deficiencies in cross-functional clinical safety documents; SOPs, and databases
• Evaluated processes, SOPs, tools and databases to identify potential improvements for changes in global regulatory
requirements and corporate initiatives.
• Updated SOPs, guidance documents, tools, manuals, and training guides for global initiatives.
• Liaised with Clinical & Safety VPs to ensure continuous improvement of activities through knowledge sharing and
integration of learning.
• Led outsourcing initiative of medical writing and document Quality Control (QC) to Novartis India.
• Identified, evaluated, and managed CROs, vendors, KOLs, and consultants for process improvement initiatives.
• Identified appropriate external medical advisors to review Risk Management of Novartis products.
• Designed, implemented, and developed meeting content and presentations for Advisory Board meetings

• Assigned Projects : Annual Safety Reports (ASR); Development Safety Update Report (DSUR); Hepatotoxicity
Guidelines & Data Collection Tools; Novartis Advisory Boards for Optimizing Safety Risk Management
Novartis Global Clinical Development & Medical Affairs
Integrated Medical Safety
Director Integrated Safety, Methods, and Innovation
February 2008- October 2009
• Promoted to Project Leader on clinical and safety document process improvement initiatives.
• Identified and evaluated process, tool, and database deficiencies; collaborated with cross functional teams and
subject matter experts to develop solutions.
• Presented evaluations and proposed solutions to senior leadership at board meetings.
• Led assigned project teams on initiatives to develop, pilot, and implement new processes, methodology, and tools to
support clinical and drug safety document compilation.
• Developed, conducted, and implemented training programs for medical safety staff and other relevant line functions
within US and Global Clinical Development on new processes, documents, tools and methods
• Liaised with Therapeutic Area VPs to ensure continuous improvement of activities through knowledge sharing and
integration of learning.
• Developing roll-out strategies and distributing corporate communications on project initiatives throughout the global
organization.
• Supported the establishment of SOPs, KPIs, metrics, quality standards, and associated monitoring tools to ensure
compliance and quality management of redesigned processes.
Novartis Clinical Development & Medical Affairs - Arthritis, Bone, GI, Urology, Neuroscience, Ophthalmic
Associate Director Project Management & Strategic Planning
March 2006 - February 2008
• Promoted to Associate Director Project Management for US Phase I-IV trials on Arthritis, Osteoporosis, Herpes,
Parkinson’s disease, Alzheimer’s Disease, Muckle-Wells Syndrome, Macular Degeneration, and various GI
indications.
• Managed the feasibility and evaluation of new clinical programs, agreement of project timelines & deliverables,
investigator selection, resources assessment, budget management and tracking, and troubleshooting of study issues;
escalated project changes to senior management.
• Liaised between global and local clinical trial operations groups, therapeutic area physicians, field scientific
operations, marketing, health economics, statistics, data management, and other departments.
• Planned, managed, and coordinated project team activities to ensure that US trials met or exceeded objectives.
• Developed strategic US recruitment plans to ensure that the US patient commitments were met.
• Created New Ophan indications and best practice guides for recruitment in niche indications.
• Designed and evaluated CRO & vendor proposals, contracts, budget, and deliverables.
• Presented project updates to senior management at US and Global Therapeutic Area Operation meetings,
International Project Teams, Therapeutic Area Boards, and Clinical Operation Review meetings.
• Departmental Responsibilities: Train & mentor Project Managers and Local Trial Leaders on operational aspects of
clinical projects & processes; Super user and trainer for Master Investigator Database (MIDB); Project team lead on
CRA development plan initiatives; Project team lead on trial feasibility task force; Project Lead for GI & NS Medical
Product Teams; US Clinical Operation Lead for Zelnorm adjudication and SAE reconciliation project for FDA recall
Novartis
US Clinical Development & Medical Affairs - Arthritis, Bone, GI, Urology
Project Manager
May 2004- February 2006
• Recruited to lead as Clinical Operations Project Manager for US Phase I-IV trials on Arthritis, Osteoporosis, Herpes,
and various GI indications.

• Led the feasibility and evaluation of new clinical programs, agreement of project timelines and deliverables,
investigator selection, resources assessment, budget management and tracking, and troubleshooting of study issues;
escalated project changes to senior management.
• Liaised between global and local clinical trial operations groups, therapeutic area physicians, field scientific
operations, marketing, health economics, statistics, data management, and other departments.
(Project Manager Continued)
• Planned, managed, and coordinated project team activities to ensure that US trials met or exceeded objectives.
• Developed strategic US recruitment plans to ensure that the US patient commitments were met.
• Designed and evaluated CRO and vendor proposals, contracts, budget, and deliverables.
• Presented project updates at US and Global Therapeutic Area Operation meetings, International Project Teams,
Therapeutic Area Boards, and Clinical Operation Review meetings.
• Departmental Responsibilities: Train and mentor Project Managers and Local Trial Leaders on operational aspects
of clinical projects & processes; Project team member for developing the Master Investigator Database (MIDB);
Project team member on developing the Project Manager workload resource tool; Project Lead for GI Medical
Product Teams
Ethicon, Inc. (a division of Johnson & Johnson) – Somerville, NJ
Global Medical Affairs
Senior Project Manager - Sutures, Needles, Mesh, Dermabond, Endoscopic Vessel Harvest Products
October 2002 – April 2004
• Led Global Project Management for pre/post-marketing studies on Ethicon and Cardiovations products across the
US, EU, South Africa, and China.
• Managed studies regulated under IDE, 510k, PMA, and European registrations.
• Designed protocols for new indications, marketing claims, and next generation medical devices/surgical products.
• Collaborated with product engineers, veterinarians, marketing, sales, and statistics to develop desired outcomes.
• Developed Protocols, CRFs, Study Guides, and other relevant documents for assigned trials.
• Designed and initiated product packaging/shipping, database and statistical plans.
• Evaluated, identified, and managed CROs for the conduct of clinical studies.
• Prepared and negotiated contracts and budgets with CROs, Consultants, and KOL Surgeons.
• Ensured vendor adherence to contracts, budgets, timelines, and regulations.
• Collaborated with statisticians to format safety and efficacy listings, tables, and figures for clinical data to be
published and/or submitted to the US and Global Health Authorities.
• Departmental responsibilities: Project team member for developing the departmental Lean Process Map (Process
Excellence/Six Sigma); Project team member on the Clinical Trial Document Management System integration
(CTDMS/TrialMinder®
)
Bayer Consumer Care – Morristown, NJ
Medical Affairs & Clinical Research
Manager, Clinical Research – Aspirin, Aleve, and Alka-Seltzer
October 2000 - October 2002
• US Clinical Manager for global Phase I-IV Analgesic and Effervescent product lines, each generating $1B+ in sales.
• Designed protocols for new indications, new formulations, and marketing claims for Aspirin and Alka-Seltzer (base
brands and line extensions).
• Designed and implemented Pharmacokinetic Phase I inpatient studies.
• Developed Protocols, CRFs, Study Guides, and other relevant documents for assigned trials.
• Designed and Set-up product packaging/shipping, database and statistical plans.
• Evaluated, identified, and managed CROs for the conduct of clinical studies.
• Prepared and negotiated contracts and budgets with CROs, Consultants, Labs, and Statisticians
• Ensured vendor adherence to contracts, budgets, timelines, and regulations.

• Collaborated with statisticians to format safety and efficacy listings, tables, and figures for clinical data to be
published and/or submitted to the US and Global Health Authorities.
• Departmental Responsibilities: Develop clinical operation strategies; Write/amend SOPs; Project team member
for the implementation of Documentum; Project team member for the evaluation of Web-based clinical trials software
systems; Develop guidelines and procedures for departmental training guides
Pharmaceutical & Healthcare Consultants – Walworth, NY
Owner / Independent Clinical Research Consultant
January 1999 – October 2000
• Hired to serve as Regional Project Manager/Consultant for CRO and Pharmaceutical Companies.
• Managed all areas of clinical research, including but not limited to Protocol development, CRF design, investigator
selection, SAE compilation/tracking, Study Manual development, and QA auditing.
• Managed and trained field CRAs; conducted performance evaluations, monitored and assessed work load issues,
and reviewed and approved Monitoring and Expense reports.
• Therapeutic Areas/Indications: Cardiology, Endocrinology, Diabetes, Anti-Obesity, Hypertension for Phase II-III
Covance , Princeton, NJ
Regional Monitoring Network – Clinical Research – Based in Naples, FL
Sr. Regional Clinical Research Associate/Project Lead /Manager
June 1994 – January 1999
• Trained and supervised Regional CRAs for a given project, and for the site management of clinical trials in Florida.
• Managed of all aspects of clinical research for assigned region including, but not limited to budgets, study supplies,
SAEs, CRFs, Data Management, QA audits, investigator site selection, initiating, monitoring, and close-outs of
studies on a variety of therapeutic agents.
• Maintained regular communication with project teams and sponsors.
• Project Responsibilities: US Phase I-IV trials within the following Indications and Diseases - Cardiology, Neurology,
Pulmonology, Endocrinology, Rheumatology, Oncology, Osteoporosis, COPD, Diabetes, Anti-Obesity, Influenza,
CHF, Hypertension, Post-Menopausal/HRT, Parkinson’s Disease, Alzheimer’s Disease, Stroke, HA/Migraine, and
Pain Management for Cancer and Chronic Back Pain
• Departmental Responsibilities: Train and mentor Regional CRAs; Review and approve monitoring reports;
develop training manuals and guidelines for regional staff; develop liaison relationships with therapeutic project
teams and sponsors
Hoffmann-La Roche, Nutley, NJ
International Clinical Research – Therapeutic Area- CNS
Sr. Clinical Research Associate
July 1991 - June 1994
• Coordinated and managed diverse aspects of Global Clinical Trials for Parkinson’s Disease studies Phases I-III.
• Organized and participated in the initiation, monitoring, and closeout of global studies.
• Collected, reviewed, and validated data generated to ensure accuracy and compliance with study protocols.
• Designed and coordinated drug packaging and distribution for US and Global clinical trials
• Collaborated on protocol and case report development.
• Developed and designed patient brochures, press releases, and consent forms.
• Supported the planning and execution of multi-center meetings; led all presentation activities.
• Prepared efficacy results and data for inclusion in NDA submissions.
• Aided medical monitor in Adverse Event tracking and coding in the ClinTrace Database.
• Departmental Responsibilities: Train and mentor junior CRAs on Parkinson trials and departmental policies;
Project team member that redesigned CRF templates and forms to streamline clinical trial data entry processes;
Project team member on pilot Electronic Data Capture (EDC) fax scanning system

Hoffmann-La Roche - Nutley, NJ
Pharmaceutical Research & Quality Control – Research Products & Biotechnology
Associate Scientist - R&D April 1989 - June 1991
Assistant Scientist – QC June 1988 - April 1989
• Associate Scientist in R&D - Developed, optimized, and validated analytical methods for testing a variety of
developmental drug candidates. Analyzed clinical supplies using analytical instrumentation. Collected and evaluated
data and procedures for inclusion in IND/NDA submissions and in the USP. Prepared written procedures and
protocols to support IND/NDA submissions.
• Assistant Scientist in QC - Ensured the quality and purity of marketed dosage forms. Monitored the stability of
marketed pharmaceutical products. Performed testing and evaluated data from analytical methods to ensure
product’s release for human consumption.
EDUCATION
BS, Chemistry, Fordham University, Bronx, NY
CERTIFICATIONS
Project Management Certification Course, George Washington University, 2005 – 2007
Green Belt, Lean Methodology, J&J Process Excellence/Six Sigma, 2003
Certified Clinical Research Associate, Certification Number A98-259, ACRP, 1998 – 2006
Licensed Realtor, NJ Department of Banking & Insurance, 2011 – Present
Real Estate Sales Training, Weichert University, 2011
PROFESSIONAL MEMBERSHIPS
Drug Information Association (DIA), 1991 – Present
Association of Clinical Research Professionals (ACRP), 1991 – 2006
Fordham University Alumni Club, 1988 – Present
PUBLICATIONS
Effect of Lazabemide on the Progression of Disability in Early Parkinson's Disease
Annals of Neurology – July 1996
COMPUTER PROFICIENCIES
Microsoft Excel, Word, PowerPoint, Outlook & Visio

Gina R DiGulielmo CV October 2016

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