Clinical Data Mgr - 8 yrs Clin Safety Asst - 3 yrs EDC Trainer 2 yrs

Curriculum Vitae

John J. Mathis, RN

**** ****** ****, #****

Morrisville, NC 27560

Mobile 941-***-****

*********@*****.***

LinkedIn Profile

March 5, 2016

SUMMARY

Senior research clinician with pharmaceutical research, corporate training, and data management experiences resulting from nearly two decades of progressive responsibilities. Demonstrated strengths include building consensus in a matrix environment, creative problem solving in extraordinary circumstances, and empathizing with both patients and co-workers. Passionate about cultivating positive relationships with vendors. Recognized for creating a mentoring environment among peers.

EDUCATION

A.S.N. Nursing Program

Ivy Technical College, Columbus, IN, May 2008

B.A. Music Performance

B.A. English Literature

Marian University, Indianapolis, IN, June 1991

Guardianship Assessment Committee Member - US 12th Circuit Court

Department of Elder Affairs, State of Florida, May 2012

Plenary Guardianship License

Department of Elder Affairs, State of Florida, Feb 2012

Indiana Nursing Licensure

Professional Licensing, State of Indiana, July 2008

Secondary Teaching Licensure

Marian University, Indianapolis, IN, August 1993

EXPERIENCE

PPD, Morrisville, NC July 2015 – present

Clinical Safety Nurse

Performs data entry of case information into the safety database including case creation, and entry of follow-up information for safety reports

Receives calls from patients, field representatives, patient support centers, clinical trial sites, spontaneous reporters, and health care professionals

Monitors the electronic mailbox, receives documents, and disseminates case information for triage

Demonstrates compliance and comprehension of the Company and Sponsor SOPs and GxP procedures

Provide ad hoc training to new hire contractors on industry specific software including IRMS, ARSg, and asset time management

ConvaTec, Greeensboro, NC October 2014 – November 2014 Clinical Safety Associate

Assisted with deploying remediation plan post-FDA inspection and citations (Form 483)

Reviewed /Corrected erroneous FDA MedWatch data submissions for resubmission

Ad hoc member of Root Cause Analysis team – confirmed user data was properly quantified

Novella Clinical, Morrisville, NC July 2013 – October 2013

In-House Clinical Research Analyst

Queried, cleaned, and managed data milestones for global clinical cancer trials

Wrote ad hoc reports in SQL environment to discover hidden safety discrepancies

Worked with data monitors in England and Germany; brought backlog into compliance

Quintiles, Morrisville, NC October 2012 – February 2013

Pharmacovigliance / Assoc. Operations Specialist

Manually coded data when libraries failed ( MedDRA, ICD-9, ICD-10, and CPT libraries)

Processed safety data from global trials for content, quality, and adherence to GCP guidelines

Reviewed safety assessment of team to insure case correctly triaged per FDA regulations

Authored clinical narratives to provide synopsis of subjects’ case and clinical progress

Lundbeck Pharmaceuticals, Deerfield, IL December 2010 - February 2011

Clinical Data Manager

Validated data transfer from Ovation / legacy systems to Lundbeck systems

Relational database cleaning for patient diaries as part of new drug submission - ONFI

Review newly created Lundbeck SOPs as part of departmental merger

Review hand written diaries for clarity, triggers, and compare to electronic data

Abbott Laboratories / Abbott Park, IL April 2010 – October 2010

Pharmacovigilance / Clinical Safety Analyst

Manually coded ICD-9 and MedDRA terms that did not autocode via “canned” reports

Reviewed safety related data from global trials for content, quality, and adherence to GCP

Triaged incoming SAEs information to fulfill time sensitive reporting guidelines

Participated in safety surveillance activities as assigned including FDA defense of sibutramine

Assisted in training on site personnel to meet FDA / GCP guidelines & Abbott SOPs

Hoosier Oncology Group, Indianapolis, IN July 2009 – April 2010

Clinical Data Manager I

Attended matrix environment meetings (MD, Stats, & IT) to discuss overall study coordination

Worked hands on with physicians to ensure protocols and data were correct

Relational Database Validation prior to UAT

Managed timelines for prepping 7 trials for ASCO 2010 presentations

Trained domestic and international site personnel on clinical data software applications

Designed study training process that meets with SOP & FDA guidelines

Coordinated eCRF design, data validation plans, and edit checks

Indiana Univ. Hospital, Simon Cancer Ctr, Indianapolis, IN May 2008 – July 2009

Registered Nurse – Oncology / Hematology

Provided nursing care on a hematology / oncology floor while floating to med/surg floors

Educated patients and family members regarding diagnosis and plan of care

Prepared and received report, administration of medications, symptom management, patient assessments, peripheral and IV blood draws, and directed both licensed / unlicensed personnel

Assisted with procedures: bone marrow aspiration, central line placement, stem cell reinfusion

“Silver Star” Award – customer service award via patient nomination

Double Spiral, LLC, Greenwood, IN Sept 2003 – Aug 2005

Vice President

Created LLC with wife who was a contract, regional CRA for both device and pharma trials

Created boilerplate documents, ‘Dear Doctor’ letters, ICF & SDF checklist, and expense report

Managed AP / AR, company master file, and payroll

Designed company website & online tutorials for typical CRC forms on InForm and Oracle Clinical

Schering-Plough Research Institute, Kenilworth, NJ July 2001 – July 2002

Sr. Technical Trainer, Electronic Data Capture (EDC)

Attended matrix style meetings to coordinate global software roll out and team education

Taught research clinicians (on-site or via web) to record clinical trial data in both US and Europe

Directed 3rd party vendor who performed same training function in S. America

Member of the SOP Implementation Committee including 21 CFR Part 11

Liaison for training materials with Worldwide Clinical Operations and Research Training

Led conversion from a classroom based learning platform to Internet based post 9-11

Abbott Laboratories / Knoll Pharma, Budd Lake, NJ June 2000 – July 2001

Senior Clinical Data Manager

Met with Medical Affairs, Statistics, & IT to discuss overall study coordination for Phase IV trials

Managed, coordinated, and served as SME for junior CDMs

Worked hands on with physicians to ensure protocols and data were correct

Assisted with physical & electronic design review of new CRF software / documents

Designed and created data validation plans and monitoring plans

Responsible for interim and final data validation and database lock

Eli Lilly & Co., Indianapolis, IN September 1998 – December 1999

Clinical Data Coordinator

Attended matrix environment meetings (MD, Stats, & IT) to discuss overall study coordination

Responsible for timeline management for locking 7 global databases within 3 months

Oriented and trained on site and overseas study personnel on software / applications

Designed novel study archiving processes that met with SOP & FDA guidelines

Coordinated report design, data validation, and data edit checks

CDMA Line management experience

Clinical Studies Ltd., Sarasota, FL July 1996 – September 1998

Clinical Research Coordinator

Followed protocol design to capture clinical data while monitoring the safety of trial subjects

Ensured trial meds management via dispensation, compliance, and variance documentation

Assisted with site activities (Subject accrual, Site start-up, IRB print / script approval, CRA visits)

Manor Care Extended Care, Sarasota, FL July 1995 – July 1996

Lead Rehabilitation Aide

Performed monitored rehabilitation therapies and exercises for PT, OT and SLP departments

Documented therapies administered and billing units for 1:1 and group activities

Monitored, maintained and ordered DME as needed for both department and residents

Sarasota Memorial Hospital, Sarasota, FL June 1993 – July 1996

Scheduler / Lead Rehabilitation Aide

Performed monitored rehabilitation therapies and exercises for PT, OT and SLP departments

Documented therapies administered and billing units for 1:1 and group activities

Acute rehab experiences include: CABG, wound care, THR, TKR, CVA, MRSA, and HIV

SUPPLEMENTAL TRAINING

ICD-9 and MedDRA Coding Train the Trainer

InForm 5.0 - Gap Training Project Management for Trainers

Brio / Visio / MS Project RECIST 1.0 tumor criteria

ICH/GCP/SOP Awareness Clinical Cross-Functional Training

Medidata Rave (Safety) J-Review Reports

Presentation Skills Workshop Adverse Event Reporting

ACCOMPLISHMENTS

Saved Abbott approx. $400,000; defined SAE error in Abbott dialysis boilerplate

Defended Meridia to FDA as member of SCOUT / sibutramine data review

Prepared BRCA data for President of American Society of Clinical Oncologists (ASCO)

“Rescued” training session in Barcelona after EDC server caught fire on site

Co-authored 21 CFR 11 SOP for Schering – Plough training paradigm shift following 9/11 attack

AWARDS / RECOGNITION

Patent pending for my organic skin cream targeting cancer survivors

Customer Service Award - Simon Cancer Center

Customer Service Award - Knoll Pharmaceuticals

Customer Service Award - Eli Lilly

Youngest member of Indianapolis Opera Theatre

PROFESSIONAL GROUPS / ACTIVITIES

North Carolina Nursing Association – Member

American Society of Holistic Nursing – Member

Morrisville Innovation Foundation – Member

Habitat for Humanity - Volunteer

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