1. Martha Schmidt
160 Hampshire Dr.  Sellersville, PA 18960
267.772.3630  mlgs2327@verizon.net
Nursing, Drug Development, and Oncology Expert
Experienced medical professional with demonstrated legal acumen.
Over twenty years of extensive experience in the medical profession with additional paralegal training.
Knowledgeable about insider practices in the pharmaceutical industry, including early development
clinical oncology and all phases of the drug development process. Passionate about assisting insurance
companies and law firms succeed in product liability and medical malpractice litigation, assisting with
case review, and serving as an expert witness.
CORE COMPETENCIES
 Clinical Trial Management  Investigator Training  FDA Audit Issues
 Protocol Development  Toxicity  Phase I, II, III, IV Trials
 Project Management  FDA Safety Regulations  NDA, IND, WMA Filings
 Drug Development  Clinical Trial Establishment  ICH Guidelines/GCP
 PI & Med. Mal. Litigation  Clinical Data Review  CDISC/SDTM Development
EXPERIENCES AND ACHIEVEMENTS
CMI/CELEGENE, Summit, NJ 2011 – Current
Delivers truly innovative and life-changing drugs for patients worldwide.
Lead Clinical Research Scientist - MCL
Reviews clinical data with a focus on regulatory compliance.
 Performs clinical data review.
 Ensures that trials are conducted according to regulatory requirements.
 Developed a risk mitigation strategy to get data cleaned for a regulatory filing.
RANDSTAND PHARMA/ASTELLAS, Northbrook, IL 2012 – 2014
Partners with the world’s leading biopharma and life sciences companies to fill industry projects.
Consultant, Principle Data Manager
Ensured compliance with federal regulations.
 Reviewed clinical data for compliance with 21 C.F.R.
IMCLONE SYSTEMS, Somerville, NJ 2012 – 2012
Dedicated to developing biologic medicines in the area of oncology.
Pharmaceutical Consultant, Study Trial Manager
Managed all aspects of clinical studies including vendor and site management, clinical data review,
review of tables, figures, and listings, CRF completion guidelines, and budgets.
 Reviewed clinical documents including protocols, Clinical Study Reports, Investigator Brochures,
and Monitoring Guidelines.
 Performed CAPA audits to ensure regulatory compliance for all required documents and prepared
for a potential regulatory audit.
GENERAL ELECTRIC HEALTHCARE, Princeton, NJ 2010 – 2012
Provides transformational medical technologies and services that are shaping a new age of patient
care.
Clinical Project Data Manager
Oversaw the clinical data review and analysis of a novel radiopharmaceutical in the oncological
therapeutic area.
 Authored protocols, presentations, and pathology manuals.
 Developed and managed timelines for study enrollment, site selection and start-up activities,

2. MATHA SCHMIDT Resume, Page 2
monthly study budget forecasting, CRO and contractor resource and budget estimates.
PROFESSIONAL EXPERIENCE CONTINUED…
GENERAL ELECTRIC HEALTHCARE
Clinical Project Data Manager
t Primary contact on clinical data issues within the clinical project management and data
management departments.
t Reviewed clinical data via data listings and tables, Statistical Analysis Plans, and coordinated
clinical monitor feedback.
t Developed and oversaw process improvement initiatives across GE Healthcare as part of a
division level committee.
MERCK & CO., North Wales, PA 2004 – 2010
One of the largest pharmaceutical companies in the world.
Clinical Oncology Researcher (2006-2010)
Manager in Clinical Research Oncology with eight direct reports and management oversight for eight
compounds including three heavy weight compounds.
t Co-clinical Subject Matter Expert for development of a specimen data collection system and
biomarker development.
t Clinical Subject Matter Expert for Merck Translational Pipeline in collaboration with a regional
cancer center consortium.
t Authored and developed clinical sections of protocols, CSR, WMA/CTD subsections, and
regulatory agency update reports. Conducted literature reviews; drafted background sections of
documents and directed the authoring activities of junior staff.
t Supported post-filing activities by authoring responses to regulatory agency requests.
Supervised the data tabulation efforts of junior staff.
Project Data Manager (2004-2006)
t Trained coworkers on basic concepts of oncology for data, statistics, IT and clinical data.
CAREER NOTE
Additional experience prior to 2004 includes: Yamanouchi USA – Associate Director, Data
Management, Aventis Pharma – Manager, Data Quality Compliance, Senior Data Management
Associate (Cardiovascular and Oncology Gene Therapy), Premier Research Worldwide – Senior
Clinical Research Associate, Manager reporting to the Vice President of Clinical Research, SCIREX
Corporation – Clinical Research Assistant, Sanofi Winthrop – Contract Clinical Research Associate
(In-house Monitor) Oncology, SmithKline Beecham – Contract Clinical Data Coordinator, Project
Lead, CDM, IMS – Contract Longitudinal Database Monitor, Medical Coder, Lutheran Deaconess
Community – Part-time Relief Charge Nurse, Church of Good Samaritan – Small Group Coordinator
– Support / Recovery Groups, Intracorp – Medical Review Specialist, Quality Health Services –
Assistant Utilization Review Supervisor, Lankenau Hospital – Registered Nurse
EDUCATION
Master of Science: Information Technology (Homeland Security Management)
University of Maryland University College, Largo, MD
Bachelor of Science: Nursing
Villanova University College of Nursing, Villanova, PA
Certificate, General Paralegal Studies
Main Line Paralegal Institute, Wayne PA
Additional Coursework

3. MATHA SCHMIDT Resume, Page 3
Temple University Graduate School of Pharmacy, Fort Washington, PA
Regulatory Affairs / Quality Assurance courses in Computer Validation in a Regulated Environment, GPX
Audits, and FDA Law.
Vicki Milazzo Institute, Legal Nurse Consulting course (2015).
EDUCATION CONTINUED…
Clinical Training Courses:
Scientific Advisory Committee-GDP training, Clinical Supplies, Medical Backgrounder, Clinical Study
Report Authoring – GDP, Medical Monitoring Process – GDP, World Marketing Application author's
seminar, Planning, Authoring, Revising, Approving Regulatory Documentation, Training for FDA
Advisory Committee Meetings, Clinical Study Initiation, Protocol Development, Introduction to Clinical
Oncology, Monitoring Oncology Trials, Novel Cancer Therapy, Nursing Stroke Conference, Adverse
Event Reporting, GCP/CRA training, ICH Conference/training on the Common Technical Document,
Authoring Investigator Brochure – Clinical Section, Statistical Concepts – Data Analysis - Basic Scientific
Reasoning
Affiliations:
Drug Information Association Data Management and Med. Terminology (MedDRA), Society for Clinical
Data Management, American Society Clinical Oncology, Oncology Nurse Society Member of 6 SIACs and
article/abstract reviewer for publications, American Chemical Society, American Association Critical
Care Nursing, Regulatory Affairs Professional Society, Food, Drug and Law Institute, Association of
Clinical Research Professionals, New York Academy of the Sciences, IEEE
ADDITIONAL QUALIFICATIONS
t Licensed Registered Nurse, Pennsylvania Board of Nursing
t Certified Clinical Data Manager (CCDM), Society of Clinical Data Management
t Legal experience, including case screening, preparing interrogatories, preparing exhibits for trial,
writing briefs and comprehensive reports, finding and interviewing expert witnesses, and interviewing
plaintiffs and defendants.
t Software Knowledge: Clinical DataFax Systems, ClinTrial versions through 4.3, Oracle Clinical, OC
TMS, SDD, SAS Viewer, SQL query builder software, eCASELINK, Clintrol, Clintrace, AERS, Impact –
Diamond and Polaris, Proprietary tissue sample tracking system, Microsoft Office, CERNER, Lablink,
MedDRA (various browsers), WHODRUG (various browsers), Pharmalink
t Training Presentations: Investigator Meetings for various pharmaceutical companies, New FDA safety
regulations, Use of Clinical Dictionaries, NCI Toxicity, Oncology Overview – disease and
chemotherapy concepts, IIR – Use of J-Medora
t Honors and Recognition: Bio IT World Best Practices, Merck-Moffitt Information Pipeline (2008),
Medora Blue Ribbon Panel, Northrop Grumman (2003, 2006), American Women, Medicine and
Healthcare, Women, Science and Engineering, World, Marquis Who’s Who, Lifetime Member, Oxford
Who’s Who, Lifetime VIP Member, Madison’s Who’s Who & Manchester Who’s Who, Service Award –
Senior Nursing Senator, Villanova College of Nursing