David Greenidge CDM Resume 2016

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DAVID CARLYLE GREENIDGE 915 Westminster Hill Road Fitchburg, MA 01420 978.342.1892 [email protected] SUMMARY Clinical data management and clinical research professional with extensive experience. Innovative project manager with vast industry knowledge and proven ability to manage data and handle project requirements. Proven ability to adapt to various data management and electronic data capture (EDC) systems. Designed processes and systems to maximize study accuracy of clinical data. Core competencies and training include: Business Objects CDISC SDTM FDA 21 CFR Part 11 Requirements Human Subjects Protection Certification ICH Guidelines Medidata Rave EDC MEDITECH Merge eClinical OS EDC Microsoft Access Microsoft Excel Microsoft Word Microsoft PowerPoint Oracle Clinical RDC Project Management Software Society of Clinical Data Management Guidelines StudyManager Evolve EDC HIGHLIGHTS OF PROFESSIONAL EXPERIENCE HAEMONETICS CORPORATION, Braintree, MA 12/2010 – Present Manager of Clinical Data Established and managed clinical research data management processes and procedures for US, EU and Chinese staff. Created new data management tools in compliance with federal regulations and industry standards. Built FDA 21 CFR Part 11 compliant EDC databases in Merge eClinical OS. Built FDA 21 CFR Part 11 compliant EDC databases in Microsoft Access. Built FDA 21 CFR Part 11 compliant EDC databases in StudyManager. Assisted in building FDA 21 CFR Part 11 compliant EDC database in REDCap. Advised on FDA 21 CFR Part 11 compliant CTMS/EDC software. Created and maintained data management plans. Advised on data management processes and procedures. Initiated multidisciplinary team collaboration to establish new data capture system. Facilitated SOP creation and modifications to match new processes. Created new research study case report forms. Managed part-time data entry contractors. MILFORD REGIONAL MEDICAL CENTER, Milford, MA 10/2009 – 06/2010 Data Manager Ensured the timely delivery of monthly and quarterly data. Facilitated 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 10/2007 – 06/2009 Database Design Project Manager Managed the delivery of Medidata Rave EDC and Oracle Clinical remote data capture databases for clients. Facilitated database design meetings for specialized study teams. Coordinated the database build activities of onshore and offshore data management personnel including monitoring the completion of projects with specified time lines. 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.

Transcript of David Greenidge CDM Resume 2016

DAVID CARLYLE GREENIDGE 915 Westminster Hill Road

Fitchburg, MA 01420

978.342.1892 [email protected]

SUMMARY Clinical data management and clinical research professional with extensive experience. Innovative project manager with vast industry knowledge and proven ability to manage data and handle project requirements. Proven ability to adapt to various data management and electronic data capture (EDC) systems. Designed processes and systems to maximize study accuracy of clinical data. Core competencies and training include:

Business Objects CDISC SDTM FDA 21 CFR Part 11 Requirements Human Subjects Protection Certification

ICH Guidelines Medidata Rave EDC MEDITECH Merge eClinical OS EDC

Microsoft Access Microsoft Excel Microsoft Word Microsoft PowerPoint

Oracle Clinical RDC Project Management Software Society of Clinical Data Management Guidelines StudyManager Evolve EDC

HIGHLIGHTS OF PROFESSIONAL EXPERIENCE

HAEMONETICS CORPORATION, Braintree, MA 12/2010 – Present

Manager of Clinical Data Established and managed clinical research data management processes and procedures for US, EU and Chinese staff. Created new data management tools in compliance with federal regulations and industry standards. Built FDA 21 CFR Part 11 compliant EDC databases in Merge eClinical OS. Built FDA 21 CFR Part 11 compliant EDC databases in Microsoft Access. Built FDA 21 CFR Part 11 compliant EDC databases in StudyManager. Assisted in building FDA 21 CFR Part 11 compliant EDC database in REDCap. Advised on FDA 21 CFR Part 11 compliant CTMS/EDC software. Created and maintained data management plans. Advised on data management processes and procedures. Initiated multidisciplinary team collaboration to establish new data capture system. Facilitated SOP creation and modifications to match new processes. Created new research study case report forms. Managed part-time data entry contractors. MILFORD REGIONAL MEDICAL CENTER, Milford, MA 10/2009 – 06/2010

Data Manager Ensured the timely delivery of monthly and quarterly data. Facilitated 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 10/2007 – 06/2009

Database Design Project Manager Managed the delivery of Medidata Rave EDC and Oracle Clinical remote data capture databases for clients. Facilitated database design meetings for specialized study teams. Coordinated the database build activities of onshore and offshore data management personnel including

monitoring the completion of projects with specified time lines. 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.

DAVID CARLYLE GREENIDGE PAGE TWO

DANA-FARBER CANCER INSTITUTE, Boston, MA 09/2003 – 05/2007 Genitourinary Medical Oncology

Clinical Research Coordinator III Responsible for study administration functions, recruiting subjects and recording data. Designed and maintained Microsoft Access databases replacing paper systems and centralizing data to

effectively obtain and access records. Performed data quality control by running and analyzing reports. Conducted data mining procedures to obtain obscure information for specific criteria. Performed manual and electronic chart reviews, recognizing and resolving incomplete and incorrect data. Approached cancer patients and families in a sensitive manner requesting permission for involvement in

research studies. Recognized by manager for outstanding demeanor. Massachusetts General Hospital, Boston, MA 01/2003-07/2003 Schizophrenia Research Program/Freedom Trail Clinic

Recruitment Coordinator/Clinical Research Coordinator II Performed activities including designing case report forms, conducting subject interviews and recording confidential subject information into database for analysis. Created and managed research subject project tracking system and database maintaining 99% accuracy of

compliance and integrity goals. Performed assessments via paper & electronic methods ensuring complete and accurate data collection. Designed case report forms. Designed and implemented data collection and storage systems, including backup and retrieval policies and

systems. Coordinated recruitment of schizophrenic subjects for multiple research studies. UNIVERSITY OF CALIFORNIA LOS ANGELES, Los Angeles, CA 03/1999 – 04/2002 Integrated Substance Abuse Programs, Data Management Center (Formally known as Friends Research and Los Angeles Area Research Consortium)

Staff Research Associate II Worked in the data management center and conducted initial patient interviews. Responsible for data acquisition, data reconciliation and information management. Managed multi-center data reconciliation providing accurate study results reflecting incorrect data on various

sides. Worked with all parties to correct and enhance procedures. Designed and maintained Microsoft Access databases replacing outdated paper and Excel systems enhancing

the ability for accurate and efficient information. Designed study budget estimation and invoicing system resulting in the receipt of federal grants. Produced monthly data status reports. Supervised data dictionary creation. Managed legacy data scanning & collection systems. Performed subject interviews. Established data collection, storage, backup, and retrieval policies and system. Ensured accurate blood and urine sample collection and storage.

EDUCATION & ACHIEVEMENTS

MBA, Nonprofit Management Concentration, Suffolk University, Boston, MA

BA, Psychology, University of Massachusetts Lowell, Lowell, MA

Psi Chi International Honor Society in Psychology Member

Society for Clinical Data Management Member