Lead Data Engineer

hace 1 mes

San José, San José, Costa Rica MSD A tiempo completo
Job DescriptionActivities may include, but not limited to:
  • Creates and develops clinical databases and data transfer files according to specified requirements.
  • Leads and participates in reviewing electronic case report forms (eCRF) and edit checks, database development, programming of edit checks, and scripts for transferring electronic data files into the Clinical Data Management System (CDMS).
  • Collaborates with study teams, including external CROs/Vendors where necessary, to integrate study team needs into all deliverables.
  • Responsible for all data mapping deliverables, including SDTM structure setup and transformation maps for supporting various clinical programs.
  • Develops mapping specifications to meet SDTM structure requirements using E2E visibility tools for ensuring data flow quality and timeliness.
  • Participates in developing transformation logic, and scripts to facilitate data flow downstream for Analysis and Reporting.
  • Oversees reporting deliverables for data cleaning, verification, and any external data captured in clinical studies.
  • Manages data reporting activities across multiple clinical programs.
  • Creates and reviews reporting specifications to ensure high-quality deliverables meeting SDTM structure requirements and business needs.
  • Participates in the review of standard and template reports, and scripts for data review to ensure database quality.
  • Manages database Archiving and Decommissioning activities for multiple clinical programs.
  • Generates PDFs using approved tools through Electronic Data Capture for data archiving.
  • Produces Final Subject PDFs for site Archival package, and creates subjects for Item 12 submission requests.
  • Handles trials decommissioning from production servers via AWS.
  • Ensures proper filing of PDFs in an official repository (e.g., Veeva Vault) TMF.
Coordinates and participates in the following activities:
  • Develops necessary training and provides ongoing training to Developers on standards and Study Build, transformations, mapping, reporting, and Archival Process.
  • Collaborates with functional manager to ensure consistency of technical and process strategies across all therapy areas.
  • Plans effectively to ensure adherence to timelines.
  • Serves as a technical resource for a functional group.
  • Integrates study teams and key stakeholders' requirements into all deliverables.
  • Ensures adherence to clinical database standards, SDTM structures, SOPs, and Process Guidelines.
  • Trains new hires and participates in the interview process.
  • Fosters a customer-oriented and proactive team attitude and contributes as a subject matter expert for troubleshooting.
  • Participates in various activities like task forces, testing of new systems, and helps coordinate technical initiatives.
  • Contributes strategies and innovative solutions to enhance processes and boost group productivity.
  • Assists Manager/Associate Director in project planning, manpower projections, and resource allocations across therapy areas.
Requirements:
  • B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant skills and experience.
  • Knowledge of database structures and tools to manage, extract, report, and warehouse data.
  • Minimum 4 years of database development or data programming experience, with at least three years in clinical databases.
  • Demonstrated strong technical proficiency in Clinical Data Management Systems (e.g., InForm, Inform Architect, Central Designer, SQL-PL/SQL).
  • Minimum 4 years of experience with CDISC Standards, XML, Java ELT tools.
  • Experience in data transformations and loading in tools like InForm.
  • Experience in System Development Lifecycle Management and system validation.
  • Experience with reporting tools like Cognos or JReview.
  • Experience in eCRF generation for site documentation and regulatory compliance deliverables.
  • Advanced knowledge of Data Management process from study start-up through close-out.
  • Strong collaboration and communication skills to interpret and ensure quality report specifications and contribute to report development.
  • Proficiency in MS Windows/Office software and exposure to web-based applications.
  • Effective communication skills (oral and written) to interact with technical and business areas.
  • Strong organizational and critical thinking abilities.
  • Urgency and customer focus.
  • Ability to work cross-functionally and as part of a team.
  • Ability to work independently, under pressure, and in a changing environment with flexibility.
  • Knowledge of drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database validation, documentation processes, and 21 CFR Part 11.

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