Rapid software learner; easily adapts to new software technologies
David Greenidge, MBA
Moreno Valley,CA
Summary
Clinical data management professional with extensive experience in overseeing clinical trial data collection and ensuring data integrity. Known for collaborative team efforts and achieving significant outcomes. Reliable and adaptable, excelling in database management and regulatory compliance, fostering high standards and results-oriented environments.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Senior Clinical Data Manager
Crinetics Pharmaceuticals
San Diego, CA
09.2022 - 02.2024
- Reviewed protocols and provided input relevant to the data management (DM) viewpoint.
- Oversaw/lead DM activities on Phase-1 & Phase-2 studies, working closely with DM CRO data managers.
- Oversaw modifications to previous Veeva CDMS electronic data capture, CDISC-compliant (EDC) build.
- Facilitated Veeva CDMS UAT.
- Facilitated Veeva CDMS maintenance.
- Facilitated ePRO set up.
- Facilitated vendor data transfers.
- Reviewed and approved DM CRO-created, DM-specific documentation & processes.
- Filed signed data management documents into the eTMF maintained by the DM CRO.
- Securely transferred DM CRO-collected external data to secure, internal, location for SAS programmers.
Senior Clinical Data Manager
Acadia Pharmaceuticals
San Diego, CA
12.2019 - 08.2022
- Reviewed protocols and provided input relevant to DM issues.
- Oversaw/lead all DM activities on Phase-1 and Phase-3 studies, working closely with CRO data managers inside and outside the United States.
- Collaborated with other functions on research study start up (e.g. CDISC-compliant CRF design, ePRO set up, etc.), Medidata Rave EDC cleanup, and Medidata Rave EDC closeout.
- Responsible for study-specific DM documentation (e.g. Data Management Plan), DB creation, DB validation, and query generation/resolution) in cooperation with study vendors.
- Responsible for clinical study data maintenance, data listings, entering queries, and reviewing query resolutions with the multifunctional study team.
Principal Clinical Data Manager
Retrophin
San Diego, CA
06.2017 - 10.2019
- Completed three Phase-1 studies from Medrio EDC database go-live to database lock.
- Managed a Phase-3 study from Medrio EDC database go-live.
- Managed three multi-year registry studies.
- Managed CROs and other clinical vendors in order to achieve corporate milestones and set deliverables.
- Ensured clean data, including facilitated data reviews; submitted queries; identified protocol deviations.
- Worked cross-functionally with other clinical research functions within the company, assessing and understanding needs; performed specific, regularly-scheduled and ad-hoc data extractions to meet needs.
- Reviewed DM-related documents produced by vendors and other functional areas.
- Facilitated ePRO set up.
- Performed database/EDC UAT.
- Updated existing and created new DMPs.
- Created and approved CRO-created EDC training presentations.
- Facilitated weekly meetings with CRO data managers.
- Weekly met and worked with SAS programmer to ensure EDC & SAS variable alignment.
Principal Clinical Data Manager
Retrophin
Cambridge, MA
05.2016 - 06.2017
- Completed three Phase-1 studies from Medrio EDC database go-live to database lock.
- Managed a Phase-3 study from Medrio EDC database go-live.
- Managed three multi-year registry studies.
- Managed CROs and other clinical vendors in order to achieve corporate milestones and set deliverables.
- Ensured clean data, including facilitated data reviews; submitted queries; identified protocol deviations.
- Worked cross-functionally with other clinical research functions within the company, assessing and understanding needs; performed specific, regularly-scheduled and ad-hoc data extractions to meet needs.
- Reviewed DM-related documents produced by vendors and other functional areas.
- Facilitated ePRO set up.
- Performed database/EDC UAT.
- Updated existing and created new DMPs.
- Created and approved CRO-created EDC training presentations.
- Facilitated weekly meetings with CRO data managers.
- Weekly met and worked with SAS programmer to ensure EDC & SAS variable alignment.
Manager of Clinical Data
Haemonetics Corporation
Braintree, MA
12.2010 - 05.2016
- Completed 33 Phase-I studies (primarily in France) from database go-live to database lock.
- Built FDA 21 CFR Part 11-compliant EDC databases in Merge eClinical OS (now IBM Clinical Development).
- Built FDA 21 CFR Part 11-compliant EDC databases in StudyManager Evolve.
- Modified FDA 21 CFR Part 11-compliant REDCap EDC database for off-site company partner.
- Created and maintained DMPs for over 33 Phase-I studies.
- Initiated multidisciplinary team collaboration to establish new, secure, global data capture system in China.
Data Manager
Milford Regional Medical Center
Milford, MA
10.2009 - 06.2010
- Facilitated MEDITECH database revisions.
- Ensured accurate delivery of clinical data to multiple, federal, government agencies (including CMS).
- Provided scheduled and ad-hoc reports to internal departments and external agencies.
- Created poster graphs for internal and external postings.
- Created standard operating procedures.
Database Design Project Manager
Accenture at Wyeth Pharmaceuticals
Cambridge, MA
10.2007 - 06.2009
- Facilitated database design meetings for multifunctional clinical research study teams.
- Coordinated the database (EDC) build activities of onshore and offshore data management personnel including monitoring the completion of projects within specified timelines.
- Updated and redesigned databases for changes and enhancements.
- Maintained database build project timelines in proprietary task-tracking tool.
- Ensured the completion of system enhancements working within a multi-national environment.
Education
MBA - Non-Profit Management
Suffolk University
Boston, MA01.2009
BA - Psychology
University of Massachusetts-Lowell
Lowell, MA02.1998
Skills
- Business Objects
- CDISC SDTM
- ClinSpark EDC
- FDA 21 CFR Part 11 Requirements
- Human Subjects Protection Certification
- ICH Guidelines (E2A-E2F, E6, E8)
- IBM Clinical Development EDC
- JReview
- Medidata Rave EDC
- Medrio EDC
- Merge eClinical OS EDC
- Microsoft Access
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Word
- Oracle Clinical RDC
- StudyManager Evolve EDC
- Society of Clinical Data Management Guidelines
- Electronic data capture
- Adverse event reporting
- Data cleaning
- Clinical data management
- Patient recruitment
- Data monitoring
- Data reporting
Accomplishments
- Implemented two different EDC systems at the same organization, ensuring data quality. Awarded recognition for outstanding study-completion results.
- Worked cross-functionally to set up and implement a secure, novel-device data capture paradigm for China (Chinese military hospitals); including created Chinese-language CRFs, and directly importing the data into the USA-based electronic data capture (EDC) system.
- Wrote and implemented Data Management standard operating procedures (SOPs), plans and processes, for less cost than was quoted by a clinical research organization (CRO) to only write the same SOPs.
- Created new tools to identify data anomalies, greatly reducing data cleaning time.
- As part of a continuous data-reconciliation process; a unique data anomaly was discovered where one subject was twice registered at two different sites on the same research study-a female at one site and a male at a different site.
- Ad-hoc data reconciliation discovered that internal fraud was ongoing.
Certification
Medidata Rave EDC Builder
Merge eClinical OS EDC Builder
Software
Timeline
Senior Clinical Data Manager
Crinetics Pharmaceuticals
09.2022 - 02.2024
Senior Clinical Data Manager
Acadia Pharmaceuticals
12.2019 - 08.2022
Principal Clinical Data Manager
Retrophin
06.2017 - 10.2019
Principal Clinical Data Manager
Retrophin
05.2016 - 06.2017
Manager of Clinical Data
Haemonetics Corporation
12.2010 - 05.2016
Data Manager
Milford Regional Medical Center
10.2009 - 06.2010
Database Design Project Manager
Accenture at Wyeth Pharmaceuticals
10.2007 - 06.2009
BA - Psychology
University of Massachusetts-Lowell
MBA - Non-Profit Management
Suffolk University