Dorothea Talley

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.

Lead oversight of complex healthcare and regulatory data management operations supporting Indiana Pathways programs. Manage data quality governance, change management, configuration control, and deficiency reporting activities. Monitor vendor performance using KPIs, metrics, and data quality indicators to ensure compliance with regulatory requirements. Analyze operational trends, identify data quality risks, and implement corrective action strategies.

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.

Executed clinical data management activities supporting diagnostic and clinical research studies in regulated environments. Conducted Study Preparation Meetings (SPMs) and collaborated with database engineers on EDC database specifications and build activities. Performed User Acceptance Testing (UAT), database validation activities, and data upload processes. Authored and maintained Data Management Plans (DMPs), CRF Completion Guidelines, and report specifications. Supported CDISC data standards implementation and clinical data quality initiatives.

• Managed CROs and vendors to ensure high-quality data management and compliance with GCP standards. • Developed and reviewed SOPs to enhance data management processes and improve service accuracy. • Communicated cross-functionally on clinical data status, risks, and readiness to stakeholders.

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

Supported global clinical trial startup and site activation activities for pharmaceutical development programs. Managed regulatory documentation, informed consent forms, budgets, contracts, and compliance tracking. Supported Trial Master File (TMF) maintenance and inspection readiness activities.

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.

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.

Served as primary clinical data management and coding liaison across enterprise clinical trial programs. Managed coding dictionaries including MedDRA and WHO Drug. Supported Oracle InForm, ClinTrial, Central Coder, and Medidata Rave clinical database systems.

• Maintained regulatory compliance for adverse event processing and reporting, ensuring adherence to timelines. • Processed adverse event reports, creating medically accurate narratives and identifying necessary follow-up documentation. • Collaborated with healthcare professionals and internal teams to enhance pharmacovigilance practices and address safety signals.

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.

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.

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.

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.

Led day-to-day clinical data management operational activities for multiple clinical development programs. Drafted eCRF designs, edit check specifications, annotated CRFs, and Clinical Data Management Plans. Conducted sponsor-side UAT activities and collaborated with external data vendors on transfer specifications. Ensured inspection readiness and compliance with ICH-GCP and FDA regulatory standards.