Job Description

Objective / Purpose:

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.

Accountabilities:

• 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.

Education & Competencies

• 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

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

• 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

This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Massachusetts - Virtual

U.S. Base Salary Range:
$154,400.00 - $242,550.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Locations
Massachusetts - Virtual

Worker Type
Employee

Worker Sub-Type
Regular

Time Type
Full time

Job Exempt
Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.