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Work Background
Eli Lilly and CompanyManager Trial Capabilities
Mar. 2022United States
Eli Lilly and CompanyAssociate Consultant
Oct. 2012 - Mar. 2022Indianapolis, Indiana Area
Endocyte Inc.Clinical Safety Associate III
Aug. 2011 - Jul. 2012Process adverse event reports using appropriate data collection tools, create concise and medically accurate narrative summaries, identify outstanding documentation and medical information to be requested for follow-up, and forward reports for review, in compliance with departmental processes.
Receive, review, and assess safety information collected during the conduct of clinical trials, and provide communication as required for issues identified.
Prepare Investigator IND Safety Reports and required regulatory documents, and provide for medical review in preparation for distribution to Clinical Investigative sites, regulatory agencies, and development/marketing partners, as required.Complete serious adverse event final reconciliation between clinical trial database and safety database for individual clinical trials, and provide required documentation to allow for database lock.Identify and communicate potential safety signals to Pharmacovigilance physician and participate in analysis of drug safety data in support of signal detestion/risk management.Provide review and recommendations for protocols, informed consent forms, amendments, Investigator Brochures, and Clinical Study Reports.
Prepare or assist with regulatory responses for specific safety concerns with investigational and marketed products.
COVANCE CLSData Manager
Aug. 2009 - Apr. 2011Perform all aspects of data management tasks from clinical trial preparation to close-out of study. Liaise between internal groups and clients in the project management of current and upcoming studies.
Ensure clinical data management project timelines are met with acceptable quality metrics.
Integrate and optimize internal standard processes, communicating issues across functions within Clinical Data Management (CDM) as well as with project management teams.
Track project progress on to update sponsors, answers questions maintain open communication about significant issues affecting protocol data.
Targanta TherapeuticsPharmacovigilance Specialist
Jul. 2008 - Dec. 2008
Eli LillyData Management Business Coordinator
May. 2003 - Oct. 2004Use previous experiences to successfully integrate, install, test and validate Clintrial๏ (new clinical data management software) into the Data management environment. Provided consultation to additional projects as well as to data management function for future enhancement initiatives. Effectively communicated business needs to IT
Audience in the form of system requirements, test scripts and validation documentation.
Eli LillyDrug Safety-Case Manager
Jul. 2000 - Jul. 2008
Eli LillyClinical Database Manager
Jul. 2000 - Oct. 2004Responsible for global data quality and consistency within the clinical data management infrastructure, which includes data collection, data validation, data archiving, enforcement of data standards, and process improvement. Responsible for development and implementation of data management processes to assure optimal design, global consistency and quality of a locked database. Responsible for the development of case report forms modules and instructions, Paper flow and Data Validation Plan and documentation of changes. Provided input into protocol design and monitoring profile.
ELI LILLY AND COMPANYSafety - Case Management Associate
Jul. 2000 - Jul. 2008Processed cases of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.
Created and updated content of post-marketing safety reports submitted to regulatory authorities, including expedited reports, PADERs, and PSURs.Managed adverse event reports from OUS-based sources, maintaining current awareness of FDA and global regulations with respect to safety reporting and pharmacovigilance.Performed initial review, entry, assessment, and acknowledgement of adverse events reports into the Lilly Safety System (LSS), ensuring completeness and technical accuracy.Completed Case Assessments, including coding to appropriate MedDRA term, Seriousness - Expectedness (Listedness), in order to evaluate the case against the appropriate labels and/or CIB.
PARKE DAVIS-WARNER LAMBERT PHARMACEUTICALSClinical Pharmacokinetics-Dynamics Research associate
Feb. 2000 - Jul. 2000
Eli LillyClinical Data Validation Coordinator
Jan. 2000 - Jan. 2001Contributed to the Study Development and Planning process, including metrics reporting, resource allocation, team coaching, and troubleshooting within the Regional Data Management Center.
LUKE'S PRESBYTERIAN HEALTH SYSTEMSClinical Pharmacokinetic Research Associate Specialist
Jan. 1999 - Jan. 2000RUSH-ST
THE MEDSTAT GROUPClinical Research Assistant
Jan. 1998 - Jan. 1999
Henry Ford HospitalSenior Research Assistant
Jan. 1998 - Jan. 1999
Henry Ford HospitalData Manager
Jan. 1997 - Jan. 1998
HENRY FORD HEALTH SYSTEMData Manager
Jan. 1997 - Jan. 1999
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