Dorit Ijeoma

About Dorit Ijeoma

Experienced and results-driven Clinical Data Management professional with 10+ years in pharma background, specializing in Risk-Based Quality Management (RBQM) and ICH E6 (R3)- compliant workflows. Hands-on experience with systems like Veeva Vault, Medidata, Pinnacle 21, and Centralized Statistical Monitoring. Adept at managing remote teams and cross-functional collaboration in fast-paced, global environments. Directed data strategy for 10+ trials, accelerating database lock timelines by 15% through streamlined UAT and query management. Expert in vendor and CRO oversight, external data integrations. KEY SKILLS & PROFICIENCIES• Clinical Data Management Leadership• Risk-Based Quality Management (RBQM)• ICH-GCP & ICH E6(R2/R3) Compliance• eTMF / EDC / Veeva Vault / Medidata Rave, SAS. R, Python, SQL• Process Optimization & SOP Development• SDLC & Change Management• Cross-Functional Collaboration• Data Visualization: Power BI, Tableau• Vendor Oversight & Technology Implementation• Quality by Design (QbD) & Central Monitoring• Project & Stakeholder ManagementTHERAPEUTIC AREASRespiratory| Immuno-Oncology| Rare Diseases | Cardio-Metabolic

Experience

1. Senior Clinical Data Manager

   Gilead Sciences

   Mar 2023 — Present · US

   Developed a Data Management playbook to define new ways of working and key accountabilities for internal and external study teams.Assessed and determined roles and responsibilities within the Data Management Team.Conducted a clean-sheet review of Data Management processes, identifying areas for improvement in line with ICH E6 (R3) and recommending technology to streamline efficiencies and reduce handoffs.Collaborated with cross-functional teams (clinical operations, site management, biostatistics, stats programming, TA) to optimize trial delivery.Applied a deep understanding of risk-based approaches and their impact on data management and site monitoring operations to deliver studies with reduced SDV.Developed and documented standard operating procedures (SOPs) for data management activities.Analyzed existing workflows to identify bottlenecks and new ways of working.Implemented best practices in data collection, cleaning, and reporting, including knowledge of Pinnacle 21, Centralized Statistical Monitoring, Quality by Design, and Risk-based Quality Management.Determined key performance indicators (KPIs) and suggested data-driven improvements.Ensured the delivery of quality, fit-for-purpose datasets by planning, building, and reviewing with the end in mind (protocol – data collection – data review – analysis – archive).Evaluated new data management tools and technologies (e.g, EDC systems, data integration platforms, data flow).Participated in system design and user acceptance testing.Modeled new technologies for staff and ensured smooth integration into new and/or modified processes.Ensured all data management activities comply with regulatory standards (e.g, FDA, EMA, ICH-GCP).Served as a liaison between data management and other departments, facilitating effective communication with clear leadership and accountability.

Education

• University of Calabar

  Bachelor of Science - BS, Chemistry

• University of Port Harcourt

  Master of Science - MS, Chemistry