Dedicated Data Specialist with more than 15 total years of experience in the clinical industry. Has significant expertise with electronic data entry (EDC), including use of RAVE, InForm, Merge, OC-RDC, Datatrak, Datatrial, Lifetree, Bioclinica Express. Has line management and staff / project training experience. Has CRO management oversight and been a clinical data liaison for a secondary “rescue” project (performed clinical data scrub, reviewed CRO Clinical and Data review, practices and documents, reviewed and updated other vendor applications and provided guidance and feedback to Sponsor for data consistency).

Senior Clinical Data Manager @ From April 2015 to Present (9 months) Raleigh-Durham, North Carolina AreaSenior Clinical Data Manager @ • Plan and manage all Clinical Data Management (CDM) activities on assigned projects • Create and maintain project documentation files • Design content of the Case Report Forms according to the protocol • Develop all components of the Data Management Plan including Data Validation Specifications, study-specific Data Entry and Medical Coding Guidelines, Electronic File Transmission Specifications • Collaborate with Clinical Programmer to facilitate database set-up and testing, including data entry screens and programmed edit checks, development and testing of data review listings. development and testing of export programs for SAS® delivery database and the development and testing of programs to import and integrate external data from third-party providers • Serve as CDM liaison to project teams assisting in problem-solving and strategizing data processing issues • Monitor receipt and processing of clinical data from start-up through database lock; prioritizing work to meet project timelines and provide feedback to monitors on backlog • Perform data review of automated and manual checks and issue queries as required to resolve data discrepancies • Review reconciliation listings of electronic data transmissions and issue queries as required to address data discrepancies • Review/perform coding of Adverse Events, medications, and medical history (as applicable) to ensure consistency and accuracy of preferred terms and classifications with similar verbatim terms; issue queries for non-specific/ambiguous terms • Provide feedback, as required, to coders • Perform and review quality review audits clearly documenting findings to facilitate resolution • Coordinate and perform database-locking activities, including final coding review and sign-off, determining that all data is received and processed, that all queries are resolved and no further discrepancies exist • Coordinate data archival activities with CDM staff to ensure that documentation is complete From August 2012 to April 2015 (2 years 9 months) Senior Data Manager @ From 2014 to 2015 (1 year) Senior Data Manager @ From 2014 to 2015 (1 year) Senior Data Manager @ From 2014 to 2015 (1 year) Senior Clinical Data Analyst @ • Provided data management project reports (metrics, work status, CDA team status, Study deliverable status) • Trained CDA staff on study specific activities • Managed transition of rescue studies From February 2012 to June 2012 (5 months) Raleigh-Durham, North Carolina AreaSenior Clinical Data Specialist @ • Performed all data management responsibilities for Phase III InForm 4.6 trial • Trained all company staff on InForm (general and study specific training) • Managed data management staff in EDC studies • Coordinated external transition of EDC study (CRO oversight) • Developed user guides and strategies for clinical site training for InForm • Created ad-hoc InForm reports for multiple departments and functions • Evaluated EDC vendors • Wrote and reviewed data management department documents • Presented InForm system and study specific demos at Investigator Meetings and global CRO offices From December 2008 to December 2011 (3 years 1 month) Data Management Specialist @ • Performed all data management study responsibilities • Evaluated and liaised with EDC vendors • Helped develop data management department standards (included CRF, Edit Check and SAS Dataset Library) • Reviewed data management documents (DMP, SOPs, WIs, etc.) From May 2007 to November 2008 (1 year 7 months) Data Manager @ • Provided Project Management of U.S. EDC studies • Developed data management practices for EDC department • Facilitated software enhancements based on study needs • Provided documentation for the clinical data management system, case report forms and validation programming used From April 2006 to April 2007 (1 year 1 month) Raleigh-Durham, North Carolina AreaElectronic Clinical Data Specialist @ • Mentored new data management leads in Inform 4.0 platform • Developed data reconciliation practices for EDC department • Coordinated and developed electronic data management department • Performed quality assurance and documentation for the InForm management system, case report forms and validation programming used From February 2005 to April 2006 (1 year 3 months) Raleigh-Durham, North Carolina AreaPharmalinkFHI @ • Defined all electronic validation checks and case report forms • Developed the consolidated data management and data entry guidelines • Coordinated the query management system functions and verified the final patient and database lock status • Coordinated and implemented the processing of central laboratory data and other externally supplied data From June 2003 to January 2005 (1 year 8 months) Associate Proposals Manager @ • Created client budgets and wrote client proposals • Maintained client contact and resolved client budgetary issues • Provided support for Director of Contracts Management and Proposal Development, Contracts Analyst and sales team From June 2001 to June 2003 (2 years 1 month) Raleigh-Durham, North Carolina AreaCDC Coordinator @ • Supported project lead and addressed issues from project manager • Trained team members and reviewed team member work and performance • Provided response and documentation to client audit From September 1998 to June 2001 (2 years 10 months) Raleigh-Durham, North Carolina Area8th Grade Language Arts Teacher @ • Created lesson plans • Supervised school sponsored events • Wrote educational grants for school stipends From August 1996 to August 1998 (2 years 1 month)

Bachelor of Arts (B.A.), English/Language Arts Teacher Education @ UNC-CH David Allan is skilled in: EDC, Clinical Data Management, Inform, CTMS, Oracle Clinical, Data Management, Clinical Trials, CRO