María Alejandra Reyes García Email & Phone Number

Mississauga, ON, CA

Mississauga, Ontario, Canada

• 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.
• 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.
• 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.

Kitchener, Ontario, Canada

• 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.
• 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.
• 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.

Colombia

• 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.
• Global status tracking, metrics preparation, and issue resolution at program level.

Bogotá D.C. Area, Colombia

• 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.
• 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.

Bogotá D.C., Colombia

• 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).

Bachelor Of Science - Bs, Microbiology

Bachelor Of Science - Bs, Biology