Martina Lewis

• Perform data management oversight activities for complex clinical trials; oversee the activities of CRO DM counterparts to ensure adherence to scope of work and service agreements, and to ensure deliverables are met in accordance with quality

• Collaborate with clinical study teams and vendors to ensure project deliverables are met, including data acquisition, quality data review, and reporting in compliance with GCP, SOPs, and regulatory requirements.

• Participate in the development of study Data Management documentation including CRF, electronic Diary Specifications, Data Management Plan, CRF Completion Guidelines, Data Validation Specification, Data Transfer Specifications, etc.

• Manage clinical trial data through review, cleaning, auditing, and validation procedures and ensure data handling compliance with regulatory requirements

• Performs oversight of third-party clinical data vendors (i.e.; electronic diary, clinical laboratory).

• Review data analysis listings and report on performance and quality; review clinical data within studies and across for trend analysis.

• Perform thorough development testing of the eCRFs and electronic Diaries before deployment, inclusive of User Acceptance Test (UAT) Plans, Test Scripts and execute testing applicable

• Collaborate with clinical study team members during the Cross-Functional Data Review for clinical studies Coordinated with clinical staff to resolve discrepancies in data entries.

• She maintained accurate documentation of all activities performed during a clinical trial.

• Worked closely with other departments such as biostatistics, medical writing, and regulatory affairs, to ensure timely completion of projects.

• Developed and tested edit checks for data entry, database development, and report generation.

• Reviewed clinical protocols and developed data management plans to ensure the accuracy of collected information.

• Effectively plan and execute multiple Data Management projects simultaneously

• Provide updates directly to senior stakeholders as requested by management

• Serve as a subject matter expert Assigns tasks and responsibilities within Data Management to team members that optimizes team capacity, delivers of timely & accurate results, and supports the needs of the business

• Communicate with cross-functional groups and stakeholders throughout the project lifecycle Manage sponsor relationships and triage issues as appropriate Perform other duties as assigned Adherence to all essential systems and processes that are required at ImmunityBio to maintain compliance to business and regulatory requirements Serve as primary contact for DM with all relevant parties both internally (e.g., Project Management, Clinical Monitoring, Biostatistics and other functional groups) and externally (e.g

• Sponsors, external vendors, investigational sites) on a regular basis throughout the study Participate in the review of study documents (e.g., protocol, (electronic) case report forms (eCRFs), safety plans/manuals and statistical analysis plan) Provide support on clinical study database set-up, including eCRF design and database validation requirements

• Develop, review and maintain project-specific DM documents including data management plans (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements

• Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks

• Create training materials for EDC users and provide project-specific training as required

• Review and validate clinical data to ensure consistency, accuracy, integrity and completeness

• Create Data Cleaning Plan in consultation with applicable functional groups and oversee data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock) Provide project metric reports, status updates, study progress, feedback, and advice to project team on site performance issues, data trends and protocol non-compliance etc

• Actively participates in the review of clinical research documents (Protocols, Case Report forms, Statistics analysis plans.) Create and maintain a Data Management Plan (DMP) throughout the project's lifespan and ensure that DMP is followed per the study's design and requirements

• Develops electronic Case Report Forms (eCRF)

• Develops and coordinates all information needed for UAT (User Acceptance Testing), including test scripts, edit checks, issue logs, etc

• Responsible for ensuring the integrity of the data and providing recommendations for corrective actions if necessary

• Coordinate with the team regarding data validation and lock of database and ensuring that the data system is in accordance with national/international regulatory guidelines

• Represent clinical data management in meetings with internal cross-functional and external customers

• Act as the Lead data management team member in clinical development Performed and supported data management activities for multiple studies in different indications

• The responsibilities include CRF development, and review, database specifications, user acceptance testing, query resolution, data review and data completion, and reconciliations (SAE, vendor data, etc.)

• Interact with Clinical Operations, Medical Monitors, and Biostatistics/Programming periodically on the progress of the data entry, and quality Interact with external data management vendors and subsidiaries of the company.

• Reviewed clinical study data with EDC systems, generated queries as needed, and worked with site data entry staff and site Clinical Research Associates (CRAs) to ensure that the data collected was accurately reported.

• Drafted data-related manuals and plans, including but not limited to the Data Management Plan (DMP), eCRF Completion Guidelines, and Data Validation Specification (DVS). Submitted manuals and plans to the Data Manager for final review and approval.

• Performed database User Acceptance Testing, including script writing and execution.

• Maintained and tracked monthly clinical research project data metrics to adequately analyze, identify, and report data and trends.

• Assisted Data Manager with data coding and maintaining appropriate WHODrug and MedDRA licenses.

• Assisted Data Manager with data reconciliation, including adverse event (AE), serious adverse event (SAE), and external lab data reconciliation.