Data Management Clinical
Resume:
DAVID CARLYLE GREENIDGE, MBA
**************@*****.***
WORK EXPERIENCE
CRINETICS PHARMACEUTICALS, San Diego, CA
Senior Clinical Data Manager Sep. 2022 – Feb. 2024 As part of the rare disease data management team, responsible for study-specific data management activities.
• Reviewed protocols and provided input relevant to the data management viewpoint.
• Oversaw/lead all data management activities on Phase-1 and Phase-2 studies, working closely with contract research organizations (CRO) data managers.
• Managed data management study activities with vendors, including facilitated external data transfers; Veeva CDMS electronic data capture (EDC) build, user acceptance testing (UAT), EDC maintenance.
• Collaborated with other functions on clinical study start up (e.g. case report form [CRF] design).
• Responsible for reviewing and approving vendor study-specific, DM-specific documentation & processes (e.g. data management plan [DMP], CRF completion guidelines [CCGs], user EDC access).
• Filed signed data management documents into the electronic trial master file (eTMF). ACADIA PHARMACEUTICALS, San Diego, CA
Senior Clinical Data Manager Dec. 2019 – Aug. 2022 Responsible for rare disease study-specific data management activities, including study set up, maintenance, data review, and database closure.
• Reviewed protocols and provided input relevant to data management issues.
• Oversaw/lead all data management activities on Phase-1 and Phase-3 studies, working closely with CRO data managers inside and outside the United States.
• Collaborated with other departments on clinical study start up (e.g. CRF design), Medidata Rave EDC clean- up, and Rave EDC closeout.
• Responsible for study-specific DM documentation (e.g. Data Management Plan [DMP]), 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.
RETROPHIN, San Diego, CA (now TRAVERE THERAPEUTICS) Jun. 2017 – Oct. 2019 RETROPHIN, Cambridge, MA May 2016 – Jun. 2017
Principal Clinical Data Manager
Managed the Data Management activities for rare disease Phase-1, Phase-3, and registry studies. Worked with and managed CROs to complete Data Management tasks on-time.
• 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 departments within the company assessing and understanding their needs; performed specific, regularly-scheduled and ad-hoc data extractions to meet those needs.
• Reviewed documents produced by vendors and other functional areas.
• Performed user acceptance testing (UAT).
• Updated existing and developed new data management plans (DMPs).
• Created and approved CRO-created EDC training presentations.
• Facilitated weekly meetings with CRO Data Managers. HAEMONETICS CORPORATION, Braintree, MA Dec. 2010 – May 2016 Manager of Clinical Data
Established and managed medical device clinical research data management processes and procedures for studies in the US, EU and China. Created new data management tools in compliance with federal regulations and industry standards.
• Completed 33 Phase-1 studies 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.
• Assisted in modifying FDA 21 CFR Part 11 compliant REDCap EDC database.
• Created and maintained data management plans.
DAVID CARLYLE GREENIDGE, MBA PAGE 2
• Initiated multidisciplinary team collaboration to establish new global data capture system.
• Facilitated standard operating procedure creation and modifications to match new processes.
• Created new research study case report forms (CRFs).
• Managed part-time data entry contractors.
• Received recognition award for outstanding results in completing trial Data Management activities. MILFORD REGIONAL MEDICAL CENTER, Milford, MA Oct. 2009 – Jun. 2010 Data Manager
Ensured the timely delivery of monthly and quarterly hospital data to federal and state regulatory authorities.
• Facilitated MEDITECH database revisions.
• Ensured accurate delivery of clinical data to various government agencies.
• Provided scheduled and ad-hoc reports to internal departments and external agencies.
• Created poster graphs for internal and external postings.
• Created standard operating procedures.
ACCENTURE AT WYETH PHARMACEUTICALS, Cambridge, MA Oct. 2007 – Jun. 2009 Database Design Project Manager
Managed the delivery of Medidata Rave EDC and Oracle Clinical remote data capture databases for one primary client.
• Facilitated database design meetings for multifunctional clinical research study teams.
• Coordinated the database 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.
• Ensured the completion of system enhancements working within a multi-national environment. EDUCATION
Suffolk University, Boston, MA
Masters in Business Administration, Non-Profit Management Jan. 2009 PROJECT
Successfully implemented remote data capture paradigm from multiple Chinese military hospitals, working directly with the company’s information technology (IT) department to setup and execute a novel remote data capture paradigm. In realtime, data was directly and securely transferred from the Chinese military hospitals into the EDC system. Due to the sensitive nature of the data transfers; it was confirmed that it was impossible to access the data during transit without utilizing the dedicated data-transfer equipment. SKILLS
• FDA 21 CFR Part 11 Requirements • IBM Clinical Development EDC • Business Objects
• ICH Guidelines • Medidata Rave EDC • JReview
• Society of Clinical Data Management Guidelines • Medrio EDC • Microsoft Access
• CDISC SDTM • Oracle Clinical RDC • Microsoft Excel
• Human Subjects Protection Certification • StudyManager Evolve EDC • Microsoft PowerPoint
• ClinSpark EDC • Veeva CDMS (EDC) • Microsoft Word
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