Kevin H. Scheuerman
Charlotte,NC
Summary
Experienced clinical trials professional in the Pharmaceutical-Biotech/CRO/ARO industry working in Clinical Data Management, assisting team members by performing various data management tasks on a number of varied therapeutic projects, from patient enrollment up to and including trial closure.
Overview
18
18
years of professional experience
Work History
Clinical Data Management Associate II - Early Phase Services, LLC
Worldwide Clinical Trials (WCT)
12.2021 - Current
- Provides support to the Clinical Data Management team in Early Phase Services through data review and database design
- Review, examine, and perform manual and automated quality checks of data to identify discrepancies and resolve data integrity issues
- Trained 4 departmental staff in data cleaning and issuing queries
- Monitor data collection real time and post collection for quality and completeness
- Assists in the tracking of and drive departmental timelines and milestones
- Design study database to ensure accurate creation of eSource and case report forms for data collection on 12 studies.
- Assist in creation of database reports
- Export clinical data listings and completed eCRF to vendors as required
Clinical Data Quality Assessment (CDQA) Spc - Clinical Data Management
International Drug Development Institute (IDDI)
11.2019 - 11.2021
- Provides information and advice for questions regarding the data, data review and quality control activities
- Provides support to the Clinical Data Management team in managing specific data (queries, labs, questionnaires, patient profiles), assist in coding (MedDRA & WHO Drug verbatim terms) and data review tasks (SAS Checks, ECG & Safety Lab) assisting the Lead Clinical Data Manager responsible for 5 projects
- Provides support to the Clinical Data Management Programming team in executing Quality Control activities (mapping, annotated CRFs) assisting the Clinical Data Programmer and Lead Clinical Data Manager responsible for the 6 projects
Sr. Clinical Data Analyst
Statistics and Data Corporation
01.2019 - 09.2019
- An active member in the Clinical Data Management/Biostatistics team environment at Statistics and Data Corporation (SDC)
- Track and maintain audit-ready clinical study documentation within the electronic Trial Master Files for multiple study projects
- Assist Clinical Data Manager in database setup including programming specification document creation, develop and review DMP, SDS, eCCG, data entry screen, validation check writing and testing
- Perform data entry and query management including data listing review, query generation and resolution
- Assist Clinical Data Manager in allocating and prioritizing workloads for multiple projects, as needed
- Serve as an interim resource for study issues pertaining to data management in the absence of the Clinical Data Manager
- Generate, send and track receipt of training forms for new database users; complete User Access Request forms
CDA III/Sr. Clinical Data Analyst (Contractor for Beacon Hill Pharma)
Syneos Health, Inc.
05.2018 - 12.2018
- Supports the Biometrics Unit by performing various clinical data management tasks (i.e., UAT, data listing review, query generation/resolution and SAE reconciliation) in compliance with Standard Operating Procedures/Work Instructions, regulatory directives, and study specific plans and guidelines
- Fulfilled original 3 month contract and received an additional 4.5 month contract extension
- Assignment complete
- Responded to CRA needs and inquiries to support Lead Project Data Manager
- Managed/administered UAW access (CRA, CRC, DM, PI) to iMedidata Rave
- Completed Vendor reconciliation (ECG, Actigraphy-rest/activity, mRS-brain, Labs)
- Performed Data Review and Query issue/resolution
- Participated in Quality Review towards database lock
Sr. Clinical Data Specialist (Contractor for Novella Clinical Resourcing)
Novella Clinical, Inc.
11.2016 - 05.2018
- Responsible for ensuring a quality database per industry standards and client specifications, while being a leader within the department as a subject matter expert for a system and/or process
- Fulfilled original contract and received two additional contract extensions
- Assignment complete
- Served as Lead Data Manager on 1 study in order to keep project on schedule until replacement was found
- Participated in both internal and external project team meetings, involving client
- Oversee/collaborated with client’s other data management vendor for data review and query management activities using listings and status reports
- Produced and reviewed metric reports for internal/external project team
- Launched new metrics report and updated DMP
- Created listings using ad hoc query tools
- Issued queries and reviewed query responses based upon the Data Review Plan, Manual Review and Reconciliation
CEC Clinical Data Specialist I (Contractor for Aerotek Scientific)
Duke Clinical Research Institute (DCRI)
12.2014 - 05.2016
- In conjunction with the Senior Clinical Data Specialist support the plan, conduct and report of data management activities within the Clinical Events Classification (CEC) group in concert with the CEC Coordinator and Project Leader
- Fulfilled original contract and received three additional contract extensions
- Assignment complete
- Trained other clinical data specialists, as well as developed work instructions for various projects, well ahead of schedule
- Prepared and sent study results files, status reports, project reports, event summaries and query reports to sponsor and project team
- Received and tracked event triggers (clinical events that require adjudication from medical reviewers), hemoglobin and status change reports
- Reconciled event triggers
Associate Data Manager
Harvard Clinical Research Institute (HCRI)
06.2007 - 06.2014
- In conjunction with the Senior Data Manager support the design of case report forms and completion guidelines, working with Clinical Affairs, Medical Affairs, Database Development, and Biostatistics to provide reliable data to the sponsor
- Participated in regular project team meetings, as with sponsor, including study start-up
- Presented data management work flow for study start-up at investigator meeting
- Handled inquiries by phone from investigator sites and sponsor during site closeout visits
- Tracked case report forms, reviewed clinical data, and updated the clinical database
- Generated and issued queries for missing or discrepant data
- Updated case report forms and clinical database through query responses
- Reviewed edit check output, case report forms and listings to identify missing or discrepant data
- Designed case report forms through protocol review; developed data management plan, and performed database user access testing
- Performed SAE Reconciliation between the Clinical and Safety databases
- Worked with participating Lab vendors to make sure all labs received for study lock
- Worked with Data Entry, developed, documented and standardized procedures that could be consistently followed to resolve almost all data entry problems, resulting in study timelines being met without delay
Education
Certificate - Ebola Virus Disease: An Evolving Epidemic (Coursera)
Emory University
Atlanta, GeorgiaCertificate - Drug Discovery (Coursera)
University of California - San Diego
San Diego, CaliforniaCertificate - Design and Interpretation of Clinical Trials (Coursera)
Johns Hopkins University
Baltimore, MarylandCertificate - Data Management for Clinical Research (Coursera)
Vanderbilt University
Nashville, TennesseeContinuing Studies - Archaeology
Stanford University
Stanford/Palo Alto, CaliforniaMaster of Arts (MA) - History
Providence College
Providence, Rhode IslandGraduate Studies - Social Sciences
University of Connecticut
Storrs, ConnecticutBachelor of Science (BS) - Liberal Studies in the Social Sciences
Southern Connecticut State University
New Haven, ConnecticutSkills
- EDC-Clinspark
- EDC-Marvin
- EDC-iMedNet
- EDC-RAVE
- EDC-InForm
- EDC-Protocol First
- EClinical OS (eCOS-MERGE)
- EDC-REDCap
- ID code
- Veeva Vault
- SAS Studio
- Xclinical
- JReview
- Pinnacle 21
- IDlog
- CEC-Tracker
- WS-FTP Pro
- Core FTP LE
- Sharepoint
- JIRA
- TOAD
- Oracle
- ClinTrial
- EDC-DataTrak
- Data monitoring
- Data reporting
- Data compliance
- Data cleansing
- Troubleshooting
- Quality assurance
- Teamwork and collaboration
- Time management
- Attention to detail
- Problem-solving
- Excellent communication
- Critical thinking
- Organizational skills
- Effective communication
- Decision-making
- Adaptability and flexibility
- Relationship building
- Team building
- Interpersonal skills
- Goal setting
- Analytical thinking
Technicalexperience - Softwareapplicationsdatabases
- EDC-Clinspark
- EDC-Marvin
- EDC-iMedNet
- EDC-RAVE
- EDC-InForm
- EDC-Protocol First
- EClinical OS (eCOS-MERGE)
- EDC-REDCap
- ID code
- Veeva Vault
- SAS Studio
- Xclinical
- JReview
- Pinnacle 21
- IDlog
- CEC-Tracker
- WS-FTP Pro & Core FTP LE
- Sharepoint
- JIRA
- TOAD (used to manage both relational and non-relational databases, using SQL)
- Oracle
- ClinTrial
- EDC-DataTrak
Therapeuticexperience
- Cardiovascular, Sickle Cell Disease, Myocardial Infarction, Coronary Artery Disease, Chronic Heart Failure, Hypertrophic Cardiomyopathy, Preeclampsia, Phase I/III, 2000-2003, 2023-2024
- Central Nervous System, Opioid Use Disorder, ADHD, Chronic Pain Syndromes, Anaphylaxis, Psychosis, Cognitive Impairment, Epilepsy, Schizophrenia, Head Trauma, Phase I/II/III, 2000-2003, 2022-2023
- Dermatological, Onychomycosis (nail fungus), Phase III, 2004-2005
- Gastroenterology, Cholestasis, Colon Purge, Overt Hepatic Encephalopathy (OHE), Phase I/II, 2019, 2022-2023
- Genitourinary, Chronic Kidney Disease, Phase I/II/III, 2004-2007, 2024
- Metabolic/Endocrine, Obesity, Diabetes, Galactosemia, Phase I/II/III, 2016-2018, 2000-2003, 2023-2024
- Musculoskeletal, DMD & BMD, Degenerative Disc Disease, Gout, Phase I/II/III, 2022, 2005-2007, 2024
- Neurological, Modified stem cells (SB623) in patients with Chronic Motor Deficit from Ischemic Stroke, Repair nerve endings in Diabetes patients, Alzheimer’s Disease, Aging Frailty, Spasticity, Phase I/II/III, 2000-2003, 2018-2019, 2024
- Oncology, ALL, Esophageal Cancer, Small Cell Lung Cancer, Prostate Cancer, Advanced Solid Tumors, Giant Cell Tumors, Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia, Multiple Myeloma, Solid Malignant Tumors, Phase I/II/III, 2017-2022, 2024
- Ophthalmology, Macular Edema due to Retinal Vein Occlusion (RVO), Dry Eye Syndrome, Phase II/III, 2019
Timeline
Clinical Data Management Associate II - Early Phase Services, LLC
Worldwide Clinical Trials (WCT)
12.2021 - Current
Clinical Data Quality Assessment (CDQA) Spc - Clinical Data Management
International Drug Development Institute (IDDI)
11.2019 - 11.2021
Sr. Clinical Data Analyst
Statistics and Data Corporation
01.2019 - 09.2019
CDA III/Sr. Clinical Data Analyst (Contractor for Beacon Hill Pharma)
Syneos Health, Inc.
05.2018 - 12.2018
Sr. Clinical Data Specialist (Contractor for Novella Clinical Resourcing)
Novella Clinical, Inc.
11.2016 - 05.2018
CEC Clinical Data Specialist I (Contractor for Aerotek Scientific)
Duke Clinical Research Institute (DCRI)
12.2014 - 05.2016
Associate Data Manager
Harvard Clinical Research Institute (HCRI)
06.2007 - 06.2014
Certificate - Drug Discovery (Coursera)
University of California - San Diego
Certificate - Design and Interpretation of Clinical Trials (Coursera)
Johns Hopkins University
Continuing Studies - Archaeology
Stanford University
Graduate Studies - Social Sciences
University of Connecticut
Certificate - Ebola Virus Disease: An Evolving Epidemic (Coursera)
Emory University
Certificate - Data Management for Clinical Research (Coursera)
Vanderbilt University
Master of Arts (MA) - History
Providence College
Bachelor of Science (BS) - Liberal Studies in the Social Sciences
Southern Connecticut State University
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