Toby Onu Msc, PMP

Experience

• 

  Advanced Clinical

  Oct 2015 - Jan 2016

  Clinical Data Associate

  ▪ Responsible for collecting, cleaning and curating imaging data and clinical metadata.▪ Assessed and developed strategies to enhance data quality; communicated with the Health Records Manager, and coding staff, regarding continuous improvement.▪ Developed Case Report Forms (CRFs) and rigorous data-cleaning techniques in collaboration with clients and team members to support protocol endpoints.▪ Tracked CRF, query trends, and data reporting to ensure a clean database lock suitable for analysis.▪ Collaborated with functional groups (including Project Management, Biostatistics, Medical, Clinical, Safety, Quality Assurance, etc.).▪ Participated in meetings and projects and carried out other duties as assigned by management.▪ Archived clinical research documents, track, and maintain all archived documents upon completion of a study. Show less

• 

  Advanced Clinical

  Oct 2016 - now

  ▪ Accountable for the data management (DM) deliverables across multiple studies and responsible for all vendor(s) oversight for outsourced DM activities.▪ Act as the main point of contact for client and vendor communication for DM Activities.▪ Creates/maintains a library of standard CRFs.▪ Review and contribute to the preparation of protocols, CRFs and prepare or review/contribute to data management plans, data management reports and CRF completion guidelines.▪ Ensures completeness, accuracy and consistency of clinical data and data structure across all projects/studies.▪ Support data management activities such as clinical data review, third party data reconciliation including ECGs, central lab, biomarker, IVRS, PK, SAE reconciliation and local lab data review.▪ Assist in database upgrades/migrations including performing User Acceptance Testing▪ Participates in study-level budget review activities for individual studies.▪ Uses metrics and key performance indicators (KPIs) to monitor vendor performance.▪ Ensures strong partnership with FSP/CRO Data Managers to ensure program level deliverables are on track.▪ Participate in vendor selection for data management, interactive response technology, and other services wherein data storage may be applicable.▪ Reports to and supports the Director, Biostatistics in departmental activities.▪ Travel as needed to execute assigned responsibilities and tasks. Show less ▪ Efficiently performed study start-up activities.▪ Assisted with the creation of test data within Medidata Rave.▪ Tracked the progress of clinical studies, ensuring projects meet timelines and expectations.▪ Managed planning, implementation, and overall direction of executing activities like protocol review electronic system configuration, validation programming and discrepancy management.▪ Managed data collection, review, and cleaning process for assigned studies.▪ Created and updated data management documentation (DMP, Data query guidelines, and self- evident SEC guidelines) as appropriate.▪ Reviewed and tested eCRF screen design and reviewed annotated eCRFs.▪ Designed and maintained databases, queries, reports, graphics and data analysis tools.▪ Generated and resolved queries and ensured adherence to relevant working practices or standard operating procedures.▪ Achieved successful and on-time EDC trial database releases.▪ Assisted senior manager during database lock. ▪ Performed ongoing data review, including reconciliation of external data and serious adverse event reconciliation with the safety database and blind data reviews (BDR).▪ Performed User Acceptance Testing (UAT) and Quality Control (QC) of clinical databases.▪ Assisted with database upgrades and migrations by performing user acceptance testing.▪ Worked with programming to coordinate Study Data Tabulation Model maps.▪ Utilize project management tools to proactively identify potential risks/mitigations (e.g. risk register), perform root cause analysis to institute effective CAPAs and facilitate change management.▪ Author database lock documentation for assigned projects.▪ Held meetings with the other teams to discuss and resolve the data management issues. Show less

  • Lead Clinical Data Manager

    Jan 2020 - now

  • Clinical Data Manager

    Oct 2016 - Jan 2020