Data Management Clinical

Dorothea Talley

317-***-**** **************@*****.***

PROFILE SUMMARY

Clinical Data Professional with progressive experience in managing multiple Phase I-IV drug, medical device protocols and healthcare data. Performs data analysis and reporting functions ensuring that project milestones are met and effectively manages compliance issues. Recognized as an effective liaison with project sponsors, investigators, support staff, study participants, and project managers, effectively utilizing knowledge of Codes of Federal Regulations, ICH Guidelines, and Global Product Safety policies and procedures.

KEY CAREER RECOGNITION

Recipient of Eli Lilly and Company’s Quality Advocate Award, 2002

Received Global Solution Achievement Award, Eli Lilly and Company, 2007

PROFESSIONAL EXPERIENCE

Senior Data Manager – Market Compliance Team

Humana Healthy Horizons, Indianapolis, IN 4/2024 – Present

Provided oversight to ensure the Contractor’s Pathways data conformed to FSSA and OMPP data standards and policies.

Monitored data management vendor quality of work through key performance metrics

Managed configuration control, data management, and deficiency reporting.

Managed data quality, change management, and data exchanges with FSSA, OMPP or its designee(s).

Responsible for data quality and verification, data delivery, change management processes used for data extract corrections, and modification and enforcement of data standards and policies for data exchanges to FSSA and OMPP as defined by the State of Indiana.

Coordinate with the State to implement data exchange requirements.

Developed and execute architectures, polices, practices, and procedures that properly manage the full data lifecycle needs of the program.

Attended technical meetings with CIO and IT team.

Clinical Data Management – Data Analyst III

Siemens Healthcare Diagnostics Inc, Tarrytown, NY 6/2022 – 4/2024

Conducted study preparation meetings (SPM).

Created and validated data management report specifications.

Worked with database engineer to create the EDC database specifications.

Responsible for uploading preliminary testing data into database.

Conducted User Acceptance Testing (UAT.)

Created CRF completion guidelines.

Created and signed off on the data management plan (DMP).

Drove the use of data standards (i.e. CDISC).

Participated in study element team meetings.

Trained end users on the eDC system.

Responsible for the addition and/or updates external users ids in GAMA.

Contributed to the departmental process improvement initiatives.

Trial Capabilities Site Engagement, Assoc Consultant – Clinical Development and Operations

ELI LILLY AND COMPANY, Indianapolis, IN 12/2020 – 5/2022

Initiated investigator site activities, including collection and submission of regulatory documents, customization and negotiation of informed consent documents, serve as the point of contact for a site’s ERB and Competent Authority (CA)(where applicable), communicate and negotiate budgets with site personnel and internal teams, negotiate and obtain fully-executed contract, track and ensure site compliance to required training, and effectively drive timelines aligned with company priorities

Communicated directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out

Ensured country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems

Leveraged previous site/review board engagements to efficiently drive new work

Populated internal systems to ensure accuracy of trial / site performance

Ensured compliance of procurements, legal and financial requirements and procedures

Populated Trial Master Files and libraries for future reference

Provide feedback and shared learning for continuous improvement

Data Analyst – Assoc Consultant - Global Master Data & Security

ELI LILLY AND COMPANY, Indianapolis, IN 8/2016 – 12/2020

Perform all tasks associated with the Data Steward role at both global and local data levels for area of support (e.g., development raw materials, intermediates, API, NDP, and Finished Goods).

This includes coordinating the approval and maintenance of key data and electronic records critical to raw materials and packaging component origination (vendor detail), identification, qualification, tracking and expiry.

Collaborate with business areas to determine impact of business/process changes on master data and network resulting global data changes across clinical supply chain according to established processes and procedures. Provide second person verification to ensure accuracy and consistency of master data.

Act as a Power User for SAP materials management, serving as the subject matter expert for PR&D end users.

Ensure data consistency and accuracy in daily work and through participation in routine data accuracy checks, reviews, and audits.

Knowledgeable of the Clinical Supply mode Global SAP system, global and local SOP’s, and participate in testing for GBIP releases.

Serve as action owner for Master Data changes.

Ensure conformance with corporate and local SOP’s applicable to SAP, item and change management/control processes.

Provide SAP QM data setup in alignment with established processes and procedures.

Data Sciences & Solutions Medical Coding Process/Technology Lead, Assoc Consultant-FDE 10/2012 – 8/2016

Responsible for providing trial leadership and ownership for companywide trials, and or programs. The broad applications of this role are:

Provides the single point of requirements definition, strategy communication, and deliverable acceptance to the vendors executing delivery of clinical data management and a single point of accountability and deliverable ownership for all aspects of clinical data management.

Acts as the primary contact to the study team and program team members for data science and data solution applications including Inform, ClinTrial, Central Coder, Metadata Rave.

Acts as a primary contact within the Data Sciences & Solutions organization for all data issues related to assigned trials and applies specialized therapeutic knowledge and data management discipline knowledge to ensure database deliverables are consistent, accurate, adherent to the data strategy, and deliver the clinical, statistical, and business demands of the team.

Acts as point of contact for management of coding dictionaries (MedDRA and WHO Drug) for the company and the dictionary browser dsNavigator.

Clinical Drug Safety Associate III

AEROTEK Scientific, Consultant for Endocyte, Inc., Indianapolis, IN 8/2011-7/1/2012

Maintain all regulatory guidelines and timelines with respect to adverse event and serious adverse event processing and reporting.

Process 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.

Maintain written communication and direct interaction with healthcare professionals/clinical study coordinators/principle investigators to pursue medical clarification and required documentation in support of pharmacovigilance surveillance responsibilities for investigational or marketed products.

Consult and collaborate with internal colleagues and external representatives of Clinical Research Organizations (CROs), third party service providers, and marketing and development partners in support of departmental needs. Identify and communicate issues that may impact compliance and provide recommendations for improved 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 detection/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.

Data Manager - COVANCE CLS, Indianapolis, IN 8/2009 – 4/2011

Perform 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.

Pharmacovigilance Specialist 7/2008-12/2008

TARGANTA THERAPEUTICS through VOLT TECHNICAL SERVICES, Indianapolis, IN

Performed various functions supporting the monitoring of safety and efficacy of Targanta marketed products and clinical study drugs.

Implemented and tested the Relsys Argus safety database, enabling the effective and accurate reporting of adverse

event cases.

Created and rolled out departmental standard operating procedures, including procedures for receiving, triaging, coding, and documenting spontaneous and clinical trial adverse events.

Prepared and reviewed MedWatch and CIOMS reports, including coding of adverse event terms and narrative; submitted safety reports to the appropriate regulatory authorities.

Effectively interfaced with CRO’s and Investigators to document, access, and report serious adverse events from

clinical trials.

ELI LILLY AND COMPANY, Indianapolis, IN 7/2000 – 7/2008

Drug Safety Case Management Associate, 2004 – 2008

Processed 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.

Provided support to call centers, the US-based Sales Force, US Patient Safety, Medical, Product Team and Brand Team personnel on Global Product Safety policies, processes and procedures related to management of adverse event reporting.

Clinical Data Management Business Coordinator, 2003 – 2004

Championed the project charged with integrating, installing, testing, and validating ClinTrial and InForm into the data management environment.

Collaborated with upper management and IT in the establishment of project architecture and strategic direction.

Documented and communicated business needs to technical teams, including system requirements, test scripts and validation documentation.

Clinical Data Management Coordinator, 2002 – 2003

Oversaw clinical data management infrastructure functionality in support of study data quality and consistency.

Implemented and enforced standard operating procedures surrounding data collection, data validation, data archiving, and process improvement, developed case report form modules and instructional documentation.

Ensured data management documents were inspection ready for FDA audits by reviewing and validating clinical data in accordance with Good Clinical Practice and ICH guidelines.

Lead and performed day-to-day Clinical Data Management (CDM) operational activities for one or more programs.

Maintained program level DM deliverable timelines in accordance with program development strategy.

Escalated timeline issues as needed.

Represented data management at cross functional team meetings providing accurate study status updates and proactive communication/escalation of data management issues and risks.

Draft eCRF design and edit check specifications; supports cross-functional review.

Performed cross-functional sponsor EDC user acceptance testing.

Interacts with external data vendors, develops data transfer agreements.

Supports development and implementation of key data and metrics reports/listings.

Drafted and performed review of DM essential documents including annotated CRF’s, eCRF Completion Guidelines, Clinical Data Management Plans and DB Go Live and Lock documentation.

Clinical Data Validation Coordinator, 2000 – 2001

Contributed to the Study Development and Planning process, including metrics reporting, CRF design, resource allocation, team coaching, and troubleshooting within the Regional Data Management Center.

ADDITIONAL EXPERIENCE

PARKE DAVIS-WARNER LAMBERT PHARMACEUTICALS, Livonia, MI 6/2000

through AEROTEK SCIENTIFIC STAFFING

Clinical Pharmacokinetic Research Associate Specialist

RUSH-ST. LUKE’S PRESBYTERIAN HEALTH SYSTEMS, Chicago, IL 1999 – 2000

Clinical Research Assistant

THE MEDSTAT GROUP, Ann Arbor, MI 1998 – 1999

Data Manager

HENRY FORD HEALTH SYSTEM, Detroit, MI 1997 – 1999

Senior Research Assistant, 1998 – 1999

Data Manager, 1997 – 1998

Staff Assistant / Interviewer, 1997

TECHNICAL SKILLS

Microsoft Office Suite AS400 CT-Man

Tableau Prep SPSS Relsys Argus

ClinTrial Windows Watson MedDRA

RDBMS (Access, DB2, and SQL Server) WHODRUG GSTMS

Medidata Rave DsNavigator Central Coder

Oracle InForm eTMF Vault Clinical

EDUCATION

MS coursework, Health Informatics – Information Management, College of St. Scholastica, Duluth, MN, 2016

BS, Interdisciplinary Studies in Social Science – Health Studies, Michigan State University, East Lansing, MI, 1997

PROFESSIONAL ASSOCIATIONS

Society for Clinical Data Management, 2001 – Present

Association of Clinical Research Professionals, 2000 – Present

American Health Information Management Association, 2004 – Present

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