Dorothea Talley

Data Analyst @Infotree

🧨 ConsultingAssociate

Dorothea Talley is a proficient Data Analyst currently working at Infotree Company. She is recognized for her exceptional analytical skills, attention to detail, and ability to interpret complex data. Dorothea has a solid background in mathematics and statistics, in which forms the foundation of her expertise in data analysis. She has a proven track record of using data-driven insights to solve complex business problems and drive strategic decision-making. Dorothea graduated with a Bachelor's degree in Computer Science and has since been committed to continuously upgrading her skills to stay abreast of the latest trends in data analysis. She is skilled at using various data analysis tools and software. Dorothea's dedication, precision, and proficiency have made her a valuable asset to any Company.

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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 LillyDrug Safety-Case Manager

Jul. 2000 - Jul. 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 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 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.

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

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