Karina

Associate Contractor

Advantage Solutions

Jul 2024 - Jan 2025 (7 months)

Coordinated and orchestrated strategic initiatives to expand product availability for clients in a user-friendly format. Reviewed procedures and updated manuals to incorporate current product information. Streamlined document management through effective archiving practices. Managed project timelines with precision.

Student

UNAM

Aug 2022 - Aug 2024 (2 years 1 month)

Engaged in webinars focused on Generative AI and LLM, providing analytical feedback to enhance professional discussions. Participated in coursework on Large Language Models, generating extensive text data to produce comprehensive reports.

Senior Clinical Data Manager

NuVasive

Apr 2022 - Jun 2022 (3 months)

Executed critical setup activities to implement the Vault Veeva System within the corporate platform for new Post Marketing Medical Devices studies. Configured workflows, reports, datasets, data transfers, patient listings, payment management, and global messaging systems. Engineered Case Report Forms, annotations, and robust guidelines. Conducted edit check listings review for final approval ensuring data integrity. Provided training and ongoing support to biostatisticians, Clinical Data Managers, and Programmers in effectively utilizing the Veeva system. Oversaw migration of SharePoint updates to enhance collaboration and data storage. Reviewed Standard Operating Procedures (SOPs) to elevate processes within the Data Management team.

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Lead Clinical Data Manager

PHARMAPACE Inc

Jan 2021 - Jun 2021 (6 months)

Directed activities for four studies utilizing Veeva, Medra, and iMedNet EDC systems. Facilitated communication and oversight directly with sponsors, monitors, and vendors throughout EDC studies. Implemented eCRF design, annotations, database specifications, and comprehensive database validation testing. Created and maintained detailed listings for external reconciliation. Performed thorough data management activities including data reviews, query resolutions, data listings reviews, and discrepancy assessments. Reviewed Non-EDC checks to ensure consistent data quality. Updated study-specific documentation as needed. Actively participated in internal and sponsor meetings to deliver essential data management support. Maintained proper storage

C

Data Manager

CERTITUDE digital

Apr 2017 - Jul 2020 (3 years 4 months)

Designed secure interim tables in Oracle to optimize query execution and data cleanliness. Supported the creation of real-world scenarios for simulation and thorough testing. Developed scripts and stored procedures to automate the extraction of specific data, enhancing workflow efficiency. Conducted data testing to ensure accuracy and reliability of outputs. Reviewed documentation, standard procedures, and amendments for submission compliance. Oversaw outsourcing activities related to database development, ensuring project alignment with business goals. Prepared and delivered informative presentations for sponsors and internal teams.

Data Associate

American Red Cross

Nov 2016 - Dec 2016 (2 months)

Facilitated data entry into the Shipping Database for the Order Management Department effectively. Managed the resolution of data entry issues, ensuring data accuracy and integrity.

SABBATICAL

Sabbatical

Oct 2014 - Oct 2016 (2 years 1 month)

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Data Manager

PROMEDICA INTERNATIONAL

Feb 2014 - Aug 2014 (7 months)

Oversaw the data management operations of multiple clinical trials, ensuring compliance with industry standards. Assisted with the structure design of clinical databases using Designer V5.2 for optimal data handling. Reviewed software requirements for various vendor systems to ensure functional alignment. Developed comprehensive data and systems validation plans to support clinical research processes. Participated in User Acceptance Testing (UAT) during study builds and for all post-production changes. Communicated effectively with vendors to establish schedules and processes for efficient data transfer. Directed interactions with Third-party organizations (TPOs) regarding all data management activities for several studies, ensuring adheren

Principal Clinical Data Manager

allergan

Feb 2008 - Jun 2012 (4 years 5 months)

Reviewed protocols and developed all study-related documentation, including Data Management Plans, CRFs, guidelines, and Data Transfer Plans, enhancing clarity and compliance. Supported the setup of IWRS systems and facilitated site/user administration for improved usability. Provided actionable guidelines and recommendations to Clinical teams, fostering effective solutions. Exercised professional judgment to introduce innovative processes within Data Management, enhancing productivity. Established strong, collaborative relationships with vendors to optimize project outcomes. Participated in User Acceptance Testing (UAT) at study builds and managed all post-production changes efficiently, ensuring timely project deliverables. Ensured adhere

Clinical Project Manager

Amgen

Aug 2006 - Feb 2008 (1 year 7 months)

Participated in the development and meticulous review of Data Management plans and accompanying documents, ensuring accuracy and completeness. Conducted thorough oversight of lab data to ensure integrity and validity throughout the research process. Assisted with SAE reconciliation and reviewed CRF data discrepancies to maintain rigorous data quality standards. Reviewed and updated Edit Check specifications to align with evolving research protocols. Ensured compliance of CRFs and Questionnaires with established industry standards. Cultivated strong partnerships with vendors to enhance collaborative efforts in data management processes.

Clinical Data Manager

Bristol-Myers Squibb

Mar 2004 - Jul 2005 (1 year 5 months)

Completed extensive training aligned with Oncology and Rheumatoid Arthritis protocols to elevate professional expertise. Contributed to the development of strategic CDM approaches, bolstering efficiency in trial execution. Represented the Data Management team at Investigational Meetings held in Miami, FL (2004) and New York, NY (2005), articulating critical data insights. Developed and delivered tailored study-specific training to site teams to enhance operational execution. Participated in listing review and tracking of paper CRFs, ensuring compliance with regulatory standards. Provided trial-level deliverable ownership for assigned studies, emphasizing timely and efficient execution of tasks. Monitored visits to international sites to ide

Data Manager

Comau

Dec 2002 - Jul 2003 (8 months)

Engineered and implemented an innovative ERP Database for production and financial interfaces, optimizing operational workflows. Assumed the role of Project Lead on a pivotal production team, steering project objectives towards successful completion.

C

Programmer and Consultant

ComUnNet

Dec 1999 - Nov 2000 (1 year)

Provided comprehensive programming services, technical support, and network configuration solutions, improving system performance and reliability.

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