Paula Lowe Email & Phone Number

Durham, Nc, Us

• Coordinate comprehensive medical care and healthcare provider interactions to optimize my mother's well-being.• Manage household finances, develop detailed budgets, and oversee healthcare and legal paperwork to ensure accurate and timely processing• Adapt to changing needs and unforeseen challenges by prioritizing tasks and making quick decisions, such as coordinating healthcare visits and reorganizing schedules to accommodate medical requirements.

Durham, North Carolina, Us

• Collaborate with project statisticians and programming teams to develop SDTM and ADaM datasets, ensuring alignment with CDISC standards and study requirements• Author key submission documents including study Define.xml, Clinical Study Data Reviewer's Guide (cSDRG), and Analysis Data Reviewer's Guide (ADRG)• Provide expert guidance to project teams on the implementation and interpretation of CDISC standards, facilitating consistency and compliance• Ensure deliverables meet FDA submission requirements and adhere to other regulatory guidance, maintaining the highest quality standards• Offer strategic input on project budgeting and scope of work to optimize resource allocation and efficiency• Conduct Pinnacle 21 Enterprise (P21E) validation to verify dataset compliance, alongside Define.xml creation• Design and annotate SDTM Analysis Case Report Forms (aCRFs) to support accurate data mapping and reporting• Review and refine SDTM and ADaM specifications to ensure clarity, accuracy, and adherence to standards• Create Trial Design Domains (TDD) to capture and communicate study design metadata effectively• Serve as a CDISC subject matter expert, providing training and mentorship to teams and supporting the adoption of best practices

Durham, North Carolina, Us

• Spearheaded development and maintenance of SDTM aCRFs, ensuring compliance with CDISC standards and streamlining data mapping processes • Collaborated with Programming Leads to architect robust SDTM Programming Specifications, establishing clear data transformation requirements and validation criteria • Designed and implemented SDTM TDD, documenting complex study elements and relationships to support regulatory submissions • Led integration initiatives for non-eCRF data sources, working closely with Programming Leads to ensure seamless data harmonization and standardization • Authored and reviewed critical submission documentation, including Study Data Reviewer's Guides, contributing to successful regulatory submissions • Executed comprehensive quality control through Pinnacle 21 validation reports, providing detailed remediation guidance to programming teams to ensure CDISC compliance • Provided expert consultation on SDTM implementation, serving as a trusted technical advisor for cross-functional teams and maintaining data standards

Raleigh, North Carolina, Us

• Served as strategic liaison between SDTM programming teams and Sponsor stakeholders, facilitating clear communication and ensuring alignment on deliverables • Orchestrated timely delivery of SDTM domains through effective project management and resource coordination, consistently meeting sponsor milestones • Led and participated in critical sponsor meetings, presenting technical solutions and driving key decisions on SDTM implementation strategies • Conducted comprehensive quality reviews of SDTM domains, ensuring strict adherence to CDISC standards and maintaining data integrity throughout the study lifecycle • Developed SDTM aCRFs customized to client-specific SDTM dictionaries, establishing clear mapping requirements for data transformation • Performed proactive CRF analysis during study startup phase, identifying potential SDTM compliance issues and recommending strategic solutions • Executed and analyzed OpenCDISC validation reports, implementing quality control measures to ensure compliance with industry standards

Brussels, Be

• Served as primary technical lead for CRF development and SDTM implementation, coordinating cross-functional initiatives and ensuring regulatory compliance • Analyzed clinical protocols to strategically determine optimal CRF library modules for efficient data collection, supporting streamlined study execution • Led quality control process for SDTM annotations, establishing standards and validating compliance with CDISC requirements across multiple studies • Managed CRO relationships and deliverables, providing oversight and guidance to ensure adherence to project timelines and quality standards • Conducted comprehensive audits of electronic trial master files, implementing quality control measures to maintain documentation integrity • Facilitated CRF and SDTM round table discussions, driving consensus among stakeholders and implementing process improvements based on collaborative feedback • Performed systematic data quality reviews using InForm platform, identifying and resolving critical data issues to maintain study integrity

Wilmington, Nc, Us

• Led oversight of monitoring activities for a team of 6 Clinical Research Associates (CRAs), ensuring quality and timeliness of monitoring reports across multiple sites • Developed comprehensive clinical trial documentation including monitoring plans, standardized templates, and training materials, establishing consistent processes across study sites • Executed full spectrum of monitoring visits from pre-study through closeout, ensuring protocol compliance and maintaining site relationships • Performed thorough source data verification of medical records and clinical documentation, maintaining data integrity and regulatory compliance • Conducted detailed eCRF review using InForm and Oracle Clinical platforms, implementing quality control measures to ensure data accuracy and completeness • Generated detailed monitoring documentation including visit reports and correspondence, maintaining clear communication channels with study sites • Implemented rigorous quality control through systematic file audits, both on-site and remotely, ensuring compliance with GCP guidelines • Maintained proactive site management through regular communication and issue resolution, driving study milestone achievement • Led drug accountability processes at multiple pharmacy locations, ensuring compliance with protocol requirements and regulatory standards • Directed training and mentorship programs for junior team members, facilitating professional development and building team capabilities

• Developed and managed comprehensive study timelines across data management, clinical operations, biostatistics, and safety teams, ensuring synchronized delivery of critical milestones • Authored detailed technical specifications for vendor selection processes, evaluating capabilities and ensuring alignment with study requirements • Led vendor and CRO relationships, providing strategic oversight and ensuring deliverable quality across multiple studies • Engineered and implemented SAS-based quality control systems to validate CRO data submissions, maintaining data integrity throughout study lifecycle • Orchestrated cross-functional review of patient profiles, facilitating collaborative data quality assessment and implementing process improvements • Directed CRF development initiatives across multiple trials, ensuring optimal data capture strategies and regulatory compliance • Led study kick-off meetings through strategic agenda development and documentation, establishing clear project objectives and team alignment • Implemented standardization initiatives for CRF and database design across study portfolio, enhancing efficiency and maintaining data consistency • Developed and maintained standard operating procedures, establishing best practices and ensuring regulatory compliance • Conducted critical analysis of study protocols during development phase, providing strategic input to optimize data collection and study execution

Durham, North Carolina, Us

• Engineered and maintained comprehensive data validation systems, implementing quality control measures to ensure data integrity throughout study lifecycle • Developed and executed data review strategies and timeline management, establishing clear processes for efficient study execution • Led critical data management milestones including database locks and transfers, consistently meeting project deadlines • Performed specialized medical coding for adverse events and concomitant medications, maintaining accuracy and compliance with industry standards • Implemented systematic reconciliation processes between safety reports and CRF databases, ensuring data consistency across platforms • Developed SQL-based solutions for study metrics analysis and data cleaning, optimizing operational efficiency • Facilitated bi-weekly sponsor communications, presenting progress updates and addressing strategic considerations • Provided technical mentorship to junior data managers across multiple teams, fostering professional development and building organizational capabilities • Served as primary technical resource for cross-functional stakeholders, delivering solutions for complex data management challenges • Created advanced SQL programs for study metric monitoring and data cleaning automation, improving operational efficiency • Managed resource allocation and budget tracking, optimizing project cost-effectiveness while maintaining quality standards

Master Of Science, Economics

Bachelor Of Science, Business Administration