Proven Leader with a recognized and consistent record for exceeding business goals within the Pharmaceutical Industry. Extensive experience in developing clinical coding conventions/processes, SOPs/OPIs, developing and delivering training programs. Experience in managing personnel in various global locations with both internal and external partners. Planning and organizational capabilities emphasizing time management, multi-tasking, attention to detail and ability to work independently. Extensive knowledge of Medical and Drug Terminologies, including MedDRA and WHO Drug. Scientific background including biology, chemistry, pharmacology, toxicology, mathematics and physiology. Extensive experience leading global, cross-functional teams and an excellent team-builder and mentor. Ability to quickly master new processes and technologies. Led large scale complex improvement initiative involving technology, systems, and process improvement. Looking for the next employment opportunity to help an organization grow through my Global Leadership skills and extensive medical experience.
CANCER INSIGHT, LLC., San Antonio, TX 8/2017-12/2017
Develop Coding SOP for company and provide Dictionary and Coding Subject Matter Expertise for first coded study for the CRO.
COVANCE, INC., Princeton, NJ 3/2013-6/2017
Deliver high quality coding for all responsible sponsor studies from beginning to end. Work with study team for all pre-study activities including coding user acceptance testing through study lock.
Participate in weekly Covance Team Meetings
Review and approve Study-specific Dictionary Coding Conventions and Specifications for assigned studies
Code Clinical data (Adverse Events, Medical history, Procedures, Medications) using the Electronic Data Capture tool Medidata Rave Coder and Clinical dictionaries MedDRA and WHO Drug
Issue/resolve queries through Medidata Coder and RAVE
Provide coding reports and issues to Covance/Study Sponsor as needed
Review coding reports and issues from Data Management and Study Sponsor
Study User Acceptance Testing
Version activities according to study-specific coding conventions
ASTRAZENECA, Wilmington, DE 1988-2013
Clinical Information Infrastructure (Clinii) Process, Standards and Quality Leader, Biometrics and Information Sciences (Secondment) (7/2012 – 2/2013)
Clinical Information Infrastructure (Clinii) Process, Standards & Biometrics and Information Sciences, Collaborate with Clinii Team on Project closure activities. Worked in close collaboration with Cognizant (CZ) personnel to drive continuous improvement on CZ process by reviewing and approving SWIs and other documentation related to Clinii tools and processes. Participated in weekly Joint Team Meetings (JTM) and monthly Operational Steering Committee (OSC) meetings. Worked with Project Management Office to ensure current Clinii information was available on Clinii Infospace. Maintained Risk Log and Engagement Plan for Clinii New Way of Working (NWW). Reviewed and approved Clinii access request forms for AZ personnel and progress requests to appropriate CZ personnel. Reviewed CZ invoices against Clinii/CZ Contract and other source material for verification of accuracy of services rendered for approval in Ariba ezBuy.
Led review of NWW documentation such as Clinii OPI, elearning, toolkit and other supporting documents for Business as usual (BAU) roll-out. Drove development of KPIs for Clinii NWW with Clinii Core Team and Cognizant. Co-ordinated training for Clinii Team, including finalizing Clinii e-learning and other team training materials.
Led Clinii Advocacy Group, cross-functional group to share Clinii experiences and raise Clinii awareness.
Clinical Dictionary Specialist, Clinical Information Standards Governance Organization (CISGO) (Jan 1/2009 – 7/2013)
Clinical Information Management (CIM) Representative on Clinical Quality Framework (CQF) Governance Team. Presented change requests to CQF Team on behalf of CIM. Provided expert advice on CQF process to CIM and CIM BALs and co-ordinate feedback on CQF documentation. Delivered high quality dictionary management as a core member of Global Clinical Dictionary Management Team. Implemented latest versions of AstraZeneca Drug Dictionary (AZDD) including: updated support documentation; maintained AZDD ACCESS database; reviewed/addressed AZDD requests via GSMRS; escalated AZDD updates from Patient Safety; reviewed AZDD for improvements; distributed new AZDD version to CROs. Led monthly WebEx/TC meeting with DMC (Cognizant) coding staff and MedImmune colleagues to discuss dictionary and coding related issues. Reviewed and provided feedback on Cognizant SOPs and working instruction documents. Reviewed and executed UAT Scripts for all versions of GSMRS, including bug fixes. Performed User Acceptance Testing on McRef. Maintained awareness of external standards. Participated in monthly European Drug Dictionary User Group meetings and regular DIA SIAC Terminology Working Group meetings. Evaluated and provided feedback to external organizations such as MSSO on topics such as their browser, proposed complex change requests, proposed changes to versioning, etc. On behalf of AZ, tested user request system for MSSO called Web CR. Represented AZ in Informal MedDRA User’s Group.
Led development of GCDMT Project plan. Created an Excel spreadsheet to gather tasks from core members of GCDMT; worked with GCDMT and appropriate CISGO personnel to annually review and update GCDMT Project Plan and Risk Analysis.
Authored and presented Global PST WebEx’s on ”Clinical Dictionaries and You”.
Developed elearning presentation for CISGO entitled ”CISGO Overview Training”. Worked with CE&L partners to ensure its release into GLMS for Global use and available for all members of ADMIRe Project.
Authored MedDRA and AZDD OPIs. Authored eLearning presentation for both OPIs. Worked with CE&L, provided voiceover for eLearnings.
Clinical Coding Specialist, Study Delivery Enablement/Regional Coding (1/2005 - 12/2008)
Global Study Implementation Team and Global coding study lead for 18,000 patient study (PLATO). Delivered coding process for study, coordinated development of Project Level Coding Conventions, managed development of medications coding schema; authored coding section of Data Management Plan; developed User Specifications and UAT test scripts for a RAVE to AZAC bridge and collaborated with WBDC vendor to implement RAVE to AZAC bridge. Managed global coding resource for delivery of coding to maximize use of a 24 hour clock; collected coding metrics. Delivered training at various departmental venues: orientation for SD new hires (SWAT initiative), MedDRA Essentials for Clinical Development, Coding SOP training for Medical Sciences Physicians at US Compliance Summit. Reviewed CRO Coding Reduction Reports (coding accuracy) for assigned CRO coded trials. Provided Coding expertise for assigned in-house studies utilizing AMOS/RAMOS/COOL/RAVE systems. Led review and updated for CRF Investigator Instructions and CRF Review Manual for multiple modules in Module Package (AELOG,HISM,HISS,MED). Provided clarification and specific examples to facilitate capture of clean, concise, codable data.
US Representative in Global Clinical Coding Network (CCN) to develop process/procedural documents for global coding group. Developed and presented training programs. Created flow charts of RAVE (PLATO vs. ASP) coding processes that became a basis for global training materials.
US Business Support Rep for AZAC. Liaised between user community and Business to provide information on process and enhancements for AZAC tool.
US Tool and Process Network Member. Assisted in writing Business Case for enhancements to AZAC.
ASP Committee Member to develop interim coding process to accommodate studies starting in RAVE that were not integrated with AZAC.
SD Employee Morale Initiative Member to identify morale issues and create possible solutions. Conducted Focus groups, and presented findings to SDLT.
Other Related Experience
Dictionary Management Content Analyst (1/1992 – 12/2004)
Managed and provided Operational and Performance Management to Clinical Data Management (CDM) Support Service’s direct report staff. Trained and assisted direct reports in authoring objectives. Ensured quarterly review and prepared annual performance evaluation for direct reports. Managed developmental training plans for direct reports. Mentored and cross trained internal and external staff. Managed and supported Clinical Dictionaries (MedDRA, WHO Drug, legacy dictionaries). Developed US coding process for AMOS database. Collaborated with members of CDM to troubleshoot issues and challenge standards for optimal effectiveness and efficiencies. Managed and presented training /mentored members of CDM and Dictionary Management.
AZAC Steering Committee Member: updated User Requirements; led Global User Acceptance testing for all new versions; AZAC Administrator/Lead User in US and coordinated all US implementation initiates.
ASG (AMOS Specialist Group) Member: provided guidance and feedback to AMOS developers to ensure consistency with Users’ needs; User Acceptance testing for new version of AMOS.
Business Project Lead in development and implementation of Global Dictionary Management Request System (GDMRS) to manage dictionary related issues and questions. Developed User requirements, led coding UAT activities, reviewed and maintained online user guide, prepared departmental announcements and summary of new system, developed training plan for GCDMT members and global Clinical Development, delivered training to US Clinical Development.
Global Clinical MedDRA Strategy Capability Project Group Member: Technical Options Workstream 2. Led proposal of functional and user requirements, analysis and recommendation for development of global coding tool AZAC and management of requests from global MedDRA users within AstraZeneca. Lead Global coder to review User requirements and led Global coding UAT for AZAC.
Global Clinical MedDRA Implementation Project Member for implementation of global training program for MedDRA. Led global training development and delivery.
Supported and maintained Terminologies subsystem of Dictionary management of medical terms, procedures and medications (DIPLOMAT) including User Acceptance testing. Developed Terminologies classification statistics database. Globally approved and classified keywords and/or reviewed proposed and accomplished classifications for consistency. Trained and mentored Dictionary Management group members. Collaborated with members of CDM to troubleshoot issues and challenge standards for optimal effectiveness and efficiencies. Trained members of CDM. Maintained report /tracking of rejected codes for distribution to CROs. Converted current dictionaries to MedDRA and coded Clinical Data in legacy and MedDRA dictionaries.
ZENECA PHARMACEUTICALS GROUP
Pharmacologist II/I, Central Nervous System Pharmacology (6/1988 – 1/1992)
Radioimmunoassay. Conducted in vitro and ex vivo receptor binding assays as primary drug screens for lead compounds. Assessed Dopamine metabolite activity in various brain regions via HPLC and thin layer chromatography. In vivo microdialysis for detection of Gamma amino butyric acid (GABA). Small animal handling and stereotaxic surgery. Handled and disposed of radioisotopes. Analyzed and graphically displayed data via VAX/VMS mainframe and related PC software packages. Prepared monthly summaries and presented quarterly progress reports at monthly inter-departmental meetings.
Post Graduate Coursework, University of the Sciences, Philadelphia, PA
Design and Analysis of Experiments (Statistics I, II)
Pharmacology I, II
Toxicology I, II
Biochemistry I, II
Biochemical Pharmacology and Toxicology
Bachelor of Arts, Biology, La Salle University, Philadelphia PA
Comprehensive working knowledge of Microsoft Office products, including Outlook, Word, Excel, PowerPoint; Internet, Medidata RAVE Coder.
Dopamine Receptor Occupancy In Vivo: Measurement using Ethoxycarbonyl-2-Ethoxy-1,2-Dihydroquinoline (EEDQ), Saller CF, Kreamer LD, Adamovage LA, and Salama AI (1989), Life Sciences, Vol 45, pp 917-929.