Associate Director, Data Validation Engineer

Takeda•USA - MA - Virtual, MA

13d•$154,400 - $242,550•Remote

About The Position

This Associate Director, Data Validation Engineer (DVE) role will work on Clinical Trial Reporting activities to deliver data listings and visualizations to facilitate the delivery of high-quality data in a timely manner, leading to statistical analysis and submission to regulatory authorities. This role partners with Clinical Data Management and works with Takeda study teams to develop listings and visualizations specifications, build and/or oversee implementation of data review objectives/artifacts for clinical trials to support the overall data review plan. In addition, this role will utilize and contribute to the development of libraries for listings and visualizations including functions and transformation templates for reuse for study level validation tasks. DVEs are responsible for maintaining, testing and documentation of programming tasks and ensuring compliance with trial master file requirements. This role operates in compliance with Takeda SOPs and processes while working closely with Clinical Data Operations Functions and others to enhance existing processes.

Requirements

BS/BA in a health-related, life science area or technology-related fields.
Minimum of 8+ years of drug development experience.
6+ years of project management and leadership experience
Experience in programming listings and/or visualizations with any of the following Veeva CDB, Elluminate and JReview
Knowledge of clinical database systems (Metadata Rave, Veeva) and experience with any of these languages: CQL, SQL, SAS, R, Python
Knowledge of data structures and data flow between clinical data management systems, vendor devices, and CDR.
Experience with managing vendors and implementation clinical technologies: (e.g., Elluminate, Veeva CDB, CluePoint, Jreview, SAS, R, RShiny)
Operational experience in pharmaceutical drug development with exposure to clinical development and data operations required for the reporting of clinical trial data (e.g. data review, regulatory submissions, safety updates, etc.)
Knowledge of FDA and ICH regulations and industry standards and quality control principles as well as best practices related to computer system validation, electronic records and signatures and data privacy.
Experience managing cross functional projects and developing successful partnerships within and across functional areas
Strong communication (written and oral), leadership, decision-making, influencing, negotiation, and project management skills

Nice To Haves

Previous experience leading programming teams and influencing senior-level management and key stakeholders is a plus

Responsibilities

Provides clinical trial reporting expertise and leadership in support of global development programs as well as post-marketing registration and non-registration studies.
Drives strategy with preferred vendors to ensure compliance to regulations and standards for associated technologies and development programs to ensure regulatory submission compliance.
Partners with Data Configuration Engineer, and Clinical Data Standards teams in the development of standard and study specific data cleaning/quality checks, study status metrics, visualizations and monitoring reports.
Organizes Clinical Trial Reporting activities for assigned clinical studies and non-clinical data cleaning activities
Foster and ensure close collaboration with study team members (e.g., EDC Developers, Data Configuration engineer, Clinical Operations, Clinical Data Managers, Statistical Programmers, Statisticians and other stakeholders) in the clinical data lifecycle and in the development /maintenance/governance of standard data review objectives and libraries
Assists with oversight of Functional Service Provider (FSP) resource allocation and strategic vendor partnerships to effectively deliver on internal and/or outsourced projects.
Might be responsible for direct line management of employees.
Establishes and maintains productive partnerships within Clinical Data Operations & Standards (CDOS), functional leaders across R&D, and third-party service providers.
Responsible for the review, development, maintenance and optimization of processes to ensure that clinical trial reporting activities are in compliance with regulatory and company requirements
Training and mentoring staff on key activities and processes.
Recognizes development needs and identifies/creates development opportunities within team
Supports the development of the clinical trial reporting talent base and identifies development needs within the area of responsibility
Contribute to the enablement of technology strategies that support clinical program activities (e.g., Cross Function Data Review and Cleaning).
Show influential strategic, execution and delivery leadership both within Takeda and outside of Takeda with vendors and partners.
Participates in oversight to Global Development Operations technology vendors to ensure that they meet regulatory requirements and on delivery of accurate and efficient solutions to support therapeutic area management of global development programs.
Represent function during internal audits and regulatory inspection in collaboration with Quality Assurance and GCP & Operational Excellence organizations.
Confirm archival and inspection readiness of clinical trial reporting Trial Master File (TMF) documents
Ensure compliance with own Learning Curricula, corporate and/or GxP requirements.