Shannon Labout CCDM





  


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Shannon Labout, CCDM

Summary

Clinical data management and standards leader with career record of pursuing and achieving excellence. Expert knowledge of ICH region clinical development processes, and implementation of industry standards (CDISC, GCDMP and GCP).


Relevant work accomplishments

Leadership and Change Management

  • Made significant conceptual and implementation contributions in an initiative to combine and harmonize the medical department systems and processes following the merger of two major railroads (1996)
  • Provided strong leadership to the data management organization at Mallinckrodt to maintain productivity through a period of transition following a merger in late 2000
  • Initiated and completed cross-training activities at Mallinckrodt to efficiently utilize resources following merger-related staff reductions in 2000-2001
  • As a junior staff member at Mallinckrodt, implemented newsletter and website initiatives to improve inter -and intra-department understanding and communication at Mallinckrodt (1997-2000)
  • Built effective partnerships with clinical operations and other R&D organizations at both Mallinckrodt and Astellas, opening the door for improved communication and process improvement activities between and across functional areas (1998-2009)
  • Initiated and led process improvement activities, and implementation of ICH GCP and industry standards at Astellas by training staff and allowing them to identify the areas that needed to be improved (2008-2009)

CDISC Standards

  • As an authorized CDISC trainer, authored / co-authored and regularly delivered off-the-shelf and customized SDTM, CDASH and general standards training to FDA (CDER, CBER , CSC and CDRH), NIH, academic research, pharmaceutical, biotechnology, medical device and CRO staff in all three ICH regions, and China (2007-present)
  • Implemented CDISC standards at three different organizations beginning in 1999, including
    • Using SDTM variable naming conventions to create and organize Oracle Clinical Global Library objects (1999-2006) at Mallinckrodt
    • Active delegate on the CDISC implementation committee providing expertise on the global SDTM implementation at PPD (2007-2008)
    • EU data management representative on the global (US, EU and Japan) standard case report forms committee, creating standard CRFs based on CDASH at Astellas (2008-2009)
  • Team lead for the development of the Non-Subject standard for the SDS team and the IE domain in CDASH, and Co-lead of the global CDASH team since 2009
  • Active sub-team lead for the development of the CDASH User Guide
  • Active participating member of several CDISC teams, including the SDS Exposure sub-team, the SHARE Content team, the CDASH DM, SC, CO, DS, LB, EG and training teams

Business and Entrepreneurialism 

  • Created a CDISC Education “Brand” to communicate the extra value of CDISC-authorized training to the user community
  • Have increased CDISC training revenue year over year (2009-2011) by creating new opportunities and building strong relationships with existing CDISC member organizations
  • Formally established a process for licensing the CDISC training to member organizations, thereby increasing revenue and giving the training program a broader and more sustainable platform
  • Have had budget responsibility up to $12/million with revenue responsibility up to $850,000 (1994-present)
  • Built a profitable CDM/CDISC consultancy (2009-2010)

Clinical Data Management

  • Performed all clinical data management processes from protocol review and CRF design through database lock, including database programming, data review and cleaning, coding, SAE reconciliation and records management (1997-2006, 2008-2009)
  • Supervising or managing CDM staff since 1998, and clerical staff since 1994.
  • Thoroughly reviewed, evaluated and written process improvement recommendations for the clinical data management processes for multiple organizations as a manager, auditor and consultant. (1999-present)
  • Authored SOPs, work instructions, training documents and checklists for all data management processes both as a supervisor / manager of CDM and as a consultant (1999-present)
  • Strong Oracle Clinical, RDC experience both as a user and as a consultant/trainer, strong familiarity with Medidata RAVE through managing staff
  • Certified Clinical Data Manager (CCDM 2004, 2007, 2010)
  • Society for Clinical Data Management (SCDM) Activities, Co-Chair of Products and Services Committee (2010), Subject Matter Expert (SME) for GCDMP chapter authoring and review (2007-present), SCDM publication contributor (2008-2009), Member of SCDM Certification Taskforce (2007- 2010), Item Writing Sub-Taskforce co-lead (2009), and SME Item Writer (2007)

Education

B.A. Organizational Leadership (emphases in psychology and information systems),
summa cum laude

  • Member Delta Epsilon Sigma national honor society
  • Coursework completed in biology, statistics, research methods and health sciences

Selected Industry Activities

 


  • Invited presenter on the topic of SAE Reconciliation at a PSDM meeting in Weesp, The Netherlands (2008)
  • Invited SME for Research Triangle Institute’s survey of clinical data management professionals on behalf of the Department of Labor (2008)
  • Invited course developer and instructor for SCDM online training (2009)
  • Invited lecturer at data management training and certification preparation at the University of Bangkok, Thailand (2010)
  • Invited presenter on data standards to the medical device industry at an AdvaMed meeting (2011)
  • Invited presenter on data standards at a DM Forum for the NIH NIAIDS research team (2011)
  • Invited CDASH and CDM SME on the NIH NINDS Data Management task force to evaluate and advise on improvements to the NINDS CDE project (2011)
  • Invited SME on the Society for Clinical Data Management EDC/eSource Taskforce (2011)
  • Frequently invited to present CDISC standards and CDM topics at various industry conferences and events

Certification
CCDM 2004, 2007, 2010





For more information about me see my Public Profile on LinkedIn.



 




www.cdisc.org