Writing fiction
JOHN J. MATHIS
Durham,USA
Summary
John is a senior clinical research (informatics) nurse with experience in oncology, endocrinology, pain management and mental health. Former employers include Eli Lilly, Indiana University, and IBM Watson Health. Project medications that advanced to market include: Alimta, Gemzar, Humira, Onfi, and Vicoden. His IBM experience included management roles (Agile, Waterfall) in which AI processing was integrated into raw data processing for UNC Lineberger and Astex/Taiho Pharmaceuticals. His compassionate bedside nursing and critical thinking experiences include oncology, general medical, and mental health. Presently, he is a charge nurse for DHHS as they integrate Epic EMR into their workflows.
Overview
24
24
years of professional experience
4
4
Certifications
3
3
Licenses
Work History
Registered Nurse / Charge
DHHS / Central Regional Hospital
05.2025 - Current
- Providing in-patient nursing care (report, RX administration, first aid, lab draws and review) and mental health support to 25+ adults diagnosed with a mental health diagnosis and who have failed in their attempt to return to the public or who are awaiting adjudication.
- Conducting close observation, violence mitigation, and suicide watch as needed to ensure patient safety and prevent harm to patients and staff.
- Provide training and education of new hires and agency staff in EMR (Epic) software, medicine administration, lab collection, unit procedures, and patient safety.
- Administered medications and treatments according to established protocols and patient care plans.
- Collaborated with interdisciplinary teams to develop comprehensive patient care strategies.
Registered Nurse / Preceptor
Emily Program
01.2024 - 03.2025
- Providing in-patient and residential nursing care (report, RX administration, first aid, lab draws and review) and mental health support to children diagnosed with a mental health diagnosis paired with eating disorders.
- Educating patients, parents, and new hires in process and procedure, insurance requirements, and clinical judgment.
- Conducting close observation and suicide watch as needed to ensure patient safety and prevent self-harm.
- Mentored new nursing staff in clinical practices and patient care protocols.
- Collaborated with interdisciplinary teams to develop individualized treatment plans.
- Maintained regulatory compliance with state, federal, and accrediting agencies through ongoing education efforts and policy updates.
Assoc. Dir. – Clinical Business Transformation
Saama Technologies
03.2022 - 06.2023
- Led app training initiatives by adding AI into clinical trial processes.
- Amended clinical trial design/programming to conform to Saama's AI / ML ingestion mapping algorithm.
- Timeline development and line management for small/medium contracts.
- Assisted clients with process conversion of EMR builds to allow AI / ML benefits for Veeva and Rave users.
- Reviewed document deliverables (e.g. DMP, ALS) for compliance with CDISC / HIPAA / FDA requirements.
- Contributed to company CDM matrix, GCDMP guidance, & product release committees.
- Worked flexible hours across night, weekend, and holiday shifts.
- Used critical thinking to break down problems, evaluate solutions and make decisions.
Clinical Data Manager / Designer
ICON, PLC
05.2020 - 03.2022
- Piloted the use of Amazon AWS to replace sFTP protocol for external vendors.
- Customer Service Awards: Solved design problem with collecting intra-tumoral injections in 3D space on an eCRF.
- Company teamwork award - teamwork during an RFP added 2 cancer trials to the oncology portfolio.
- Created study-specific training manuals reinforcing AI integration.
Clinical Data Manager / Designer
IBM Watson Health
05.2016 - 11.2019
- Designed 20 new clinical trial databases from client protocol and CRFs for Phase I-III trials, registry trials, and adjudication.
- Project manager for weekly meetings with client, managed process deliverables and customer timelines.
- Brought medical and clinical process thinking into the programming process.
- Introduced coding dictionaries (ICD-9, CPT, WHODrug, ARGUS) into programming process.
- Lead EDC initiatives: new shippers (web services and sFTP), payment (Greenphire).
- Identified process improvements (e.g. introducing CDISC standards to clients).
- Clinical SME to various Watson Health teams.
Pharmacovigilance Nurse - Contract
ConvaTec
11.2013 - 02.2014
- Assisted in the deployment of remediation plan following RCA and issuance of FDA Form 483.
- Evaluated five years of consumer complaints across four product lines for potential AEs / SAEs.
- Utilized Oracle Clinical and ARISg system (and WHO Drug) for creating / amending cases.
- Consulted with upper management after the failure of first remediation plan.
- Assisted with the creation of a second remediation plan; accepted by FDA.
- Performed 1st round of clinical assessment; wrote associated MedWatch forms.
Clinical Nurse Monitor - Contract
Novella Clinical
07.2013 - 10.2013
- Short-term contract preceding purchase by Quintiles.
- Provided pre-database lock data review for oncology trial; transitioned to a NDA mid-study.
- Expedited query cycle within InForm environment.
- Provided training / logistical support to Clin Ops based in Europe / Asia.
- Resolved escalated issues presented by Regional CRAs / Study Project Managers.
- Rescued data from three sites with superior customer service skills.
Pharmacovigilance Specialist RN - Contract
Quintiles
11.2012 - 02.2013
- Short-term contract to address bolus of clinical data as 21,000 global subjects with a common study end date.
- Utilized ARISg and proprietary systems to create or amend SAE cases.
- Composed initial and amended follow-up of MedWatch clinical narratives.
- Entered MedDRA / WHO Drug code when auto-coding verbatims failed.
- Reviewed digital documents for completeness; noted deviations to prevent CAPA.
Senior Clinical Data Manager - Contract
Lundbeck Pharmaceuticals
11.2010 - 02.2011
- Assisted CDM by increasing department bandwidth as they transitioned from being Ovation Pharmaceuticals.
- Assisted multiple teams while reviewing new SOPs for quality and completeness.
- Discovered process error in self-evident corrections as part of DVP boilerplate.
- Reviewed all boilerplate documents in CDM.
- Scanned and manually uploaded patient and caregiver diaries.
Clinical Safety Analyst (RN) - Contract
Abbott Laboratories / AbbVie
04.2010 - 10.2010
- The Clinical Safety Analyst was responsible for AE / SAE processing from intake to close.
- This included dossier creation, Medical Director review, narrative creation, and MedWatch 1500A form completion.
- Job included defense of sibutramine / Meridia.
- Ensure SAEs from clinical trials are processed according to FDA / SOP guidelines.
- Prepared adjudication briefs for Medical Monitor, Sponsor Physician, and Legal.
- Reviewed safety related data for content, quality, and adherence to GCP guidelines.
Clinical Data Manager
Hoosier Oncology Group / Indiana University
07.2008 - 04.2009
- A 19-person CRO where many tasks fell outside CDM scope such as protocol development and investigator training since we did mostly Investigator Initiated Trials (IIT).
- Solvency issues arose when Eli Lilly redirected their trials to a larger CRO once Phase II was approved.
- CDM services included data review for signal, data collection /validation plan creation, query resolution, database design for different tumor criteria (WHO vs RECIST).
- Assisted with site identification, selection, and post hoc site training.
- Co-developed a biorepository of cancer slides from globally sourced tissue samples.
- Assisted the President of ASCO for one paper and 2 posters of the BRCA1 ER- / HER- gene variant.
Sr. Technical EDC Trainer
Schering-Plough Research Institute
07.2001 - 07.2002
- Assisted in EDC platform selection for Schering-Plough and expedited transition from paper to electronic during the 9/11 crisis.
- All study timelines were met in spite of this paradigm shift.
- Directly managed the US / European process and managed outside vendor for South American studies and personnel.
- Met with leaders regarding EDC to coordinate roll out and education of global team.
- Taught clinicians / opinion leaders use Inform in US and Europe.
- Attended Investigator Meetings and trained study site personnel in Inform.
- Member of the SOP Implementation Committee including 21 CFR Part 11.
- Converted classroom-based learning platform to Internet-based post 9/11.
Education
Bachelor of Arts - English Literature
Marian University
Indianapolis, INBachelor of Arts - Music Performance
Marian University
Indianapolis, INTeaching License - Secondary Education
Marian University
Indianapolis, INAssociate of Science - Nursing
Ivy Community College
Columbus, INSkills
- Electronic Data Capture
- Electronic Medical Records
- Certified Clinical Data Manager
- Protocol design
- Database design
- Data interpretation
- Data validation techniques
- Medical coding
- Clinical trial monitoring
- Health records review
- HIPAA and HITECH requirements
- Clinical documentation
- Training and mentoring
- Quality improvement
- Health information systems
- Trained in Epic, Rave, Inform, Veeva, J-Review
- Proficient in MS Project, Jira, ServiceNow
- Corporate liaison
- Daily facility operations
- Teamwork and collaboration
- Multitasking
- Organizational skills
- Adaptability and flexibility
- Relationship building
- Medical terminology
- Training and development
- Risk assessment
- User acceptance testing
- Strategic planning
- Continuous improvement
- Project management
- Compliance monitoring
- Problem-solving aptitude
- Data validation
- Process improvement
- Vendor management
- Regulatory compliance
- Discrepancy management
- SOP development / compliance
- Query generation
Accomplishments
- Mentorship Service Award 2023 – teaching new female graduates in India the fundamentals of clinical trial design, networking, and resilience through the LeanIn program.
- Inspire Award 2021 - pioneered use of Amazon AWS, Cyberduck, and EKG wearable device to support Fitbit trials.
- Inspire Award 2020 - knowledge of Intra-Tumoral Injection studies lead sponsor to award ICON two additional studies.
- Medications (brought to market): Actos (pioglitazone), Alimta (pemetrexed), FloMax (tamsulosin), Humira (adalimumab), and Imitrex (sumatriptan).
Certification
CCDM
BLS
Rave Designer
IBM-PMP
PROFESSIONAL DEVELOPMENT
- EPIC Hyperspace Training - DHHS
- Project Management for Trainers - Langevin
- EMR (Rave) User Training & Designer Training - Metadata
- EClinical (Meritive) Designer Training and Certification - IBM
- IBM Clinical Development Designer Certification - IBM
- Cross Training: SAS VA, Smart Reports, J-Review, CTMS, ePRO
- Metadata Rave Designer Training - ICON University
- 300+ credit hours in continuing education - NCNA
Interests
Woodworking
Pets
Paranormal research
Organic cosmetics development
Timeline
Registered Nurse / Charge
DHHS / Central Regional Hospital
05.2025 - Current
Registered Nurse / Preceptor
Emily Program
01.2024 - 03.2025
Assoc. Dir. – Clinical Business Transformation
Saama Technologies
03.2022 - 06.2023
Clinical Data Manager / Designer
ICON, PLC
05.2020 - 03.2022
Clinical Data Manager / Designer
IBM Watson Health
05.2016 - 11.2019
Pharmacovigilance Nurse - Contract
ConvaTec
11.2013 - 02.2014
Clinical Nurse Monitor - Contract
Novella Clinical
07.2013 - 10.2013
Pharmacovigilance Specialist RN - Contract
Quintiles
11.2012 - 02.2013
Senior Clinical Data Manager - Contract
Lundbeck Pharmaceuticals
11.2010 - 02.2011
Clinical Safety Analyst (RN) - Contract
Abbott Laboratories / AbbVie
04.2010 - 10.2010
Clinical Data Manager
Hoosier Oncology Group / Indiana University
07.2008 - 04.2009
Sr. Technical EDC Trainer
Schering-Plough Research Institute
07.2001 - 07.2002
Bachelor of Arts - English Literature
Marian University
Bachelor of Arts - Music Performance
Marian University
Teaching License - Secondary Education
Marian University
Associate of Science - Nursing
Ivy Community College