• Performs data management activities for one or more clinical trials and registry projects for clients globally. Effective management of all data and reports to review subject records and issuing/resolving queries where applicable based on edit check outputs to meet integrity, quality, validity, and reliability in accordance which project and sponsor guidelines, industry best practices and regulatory standards.• Collaborate with creation and updates of data management documents including Data Management Plans, Data Integrity Plans, and Data Export Specifications, Data Validation Plan, Data Listing Specifications, eCRF as per Client request.• Liaise with sponsors, sites, project teams, and third-party service providers to address data issues and queries to ensure stakeholders remain current on project requirements and manage sponsor expectations. • Provide ongoing support for the management of the project and associated ancillary initiatives, (including assisting with interim analyses, database closeout/locks, reconciliations, and coding) by working with internal project teams and external clients to coordinate all final database lock processes.

• Perform assigned routine standard testing within a team environment in accordance with existing SOPs (bacterial assay, cell culture-based assays), as long with the preparation of various media, solutions, and samples for the corresponding assay.• Responsible for the timely and accurate completion and verification of related documents to ensure on time delivery of test results. (e.g., data in LIMS, worksheets, logbooks, test requisitions, verification of calculations for accuracy, verification of entries and transcription of data, review of electronic data including audit trails, as applicable).• Following the standards ISO 1725 and GLP (Good Laboratory Practices), ensuring that all the equipment used in the studies is verified, calibrated, and properly maintained prior to use: guaranteeing the correct operation of instruments, cleaning, and disinfecting workspace to provide high quality in the executed tasks.

• Triage, research, discuss and resolve the reports outputs provided by Clinical & Statistical stakeholders at a protocol level during in-life and database lock stages.• Execute special reports in different systems and coordinate resolution of the outputs.• Responsible for the preparation, creation, validation, and review of data management tool specifications, including: Electronic Case Reports Forms (eCRFs), Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-life Reports, Encoding, and Data Management Plans (DMPs).• Global status tracking, metrics preparation, and issue resolution at program level.

• Responsible for executing end-to-end data management activities pertaining to clinical trials including data reconciliation, query management, medical coding, and database lock preparation in compliance with Standard Operating Procedures (SOPs) and ICH-GCP (Good Clinical Practices) guidelines.• Raised questions to investigational site staff and internal and external vendors, reviewed responses, and corresponding data corrections to confirm identified issue resolution.• Team coordination, CDMs/Sites training, and mentoring for high-priority protocols.• Responsible for the execution of user acceptance testing of data management tools under the guidance of the Senior Clinical Data Manager/Lead Clinical Data Manager. Escalates overdue items, including but not limited to outstanding questions and missing visits.

• Responsible for reviewing and assuring methodologies were performed in accordance with ISO normativity requirements.• Evaluation of samples collected from raw material, finished products, surfaces, environment, and operators, among others.• Create Standard Operating Procedures (SOPs) to guarantee processes are followed within GMP (Good Manufacturing Practices).