<p style="text-align:left">By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s <a href="https://jobs.takeda.com/privacynotice" target="_blank" rel="noopener noreferrer">Privacy Notice</a> and <a href="https://www.takeda.com/terms-and-conditions/" target="_blank" rel="noopener noreferrer">Terms of Use</a>.  I further attest that all information I submit in my employment application is true to the best of my knowledge.</p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><h2><b>Job Description</b></h2><p style="text-align:inherit"></p><h3><span> </span>Objective / Purpose: </h3><h3></h3><h3><span>Th<span>is Associate Director, Data Validation <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">Engineer (DVE) role </span></span><span>will work on Clinical Trial Reporting activities to deliver data listings and visualizations to </span><span>facilitate</span><span> t</span><span>he delivery of high-quality data </span><span>in a timely manner</span><span>, leading to statistical analysis and submission to regulatory authorities. </span><span>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. </span><span>In addition, this role will </span><span>utilize</span><span> and contribute to the development of libraries for listings and visualizations including functions and transformation templates for reuse for study level validation tasks. DVEs </span><span>are responsible for</span> <span>maintaining</span><span>, testing and documentation of programming tasks and </span><span>ensuring</span><span> compliance with trial master file requirements. </span><span>This role </span><span>operates</span><span> in compliance with Takeda SOPs and processes while working </span><span>closely with</span><span> Clinical Data Operations Functions and others to enhance existing processes.</span></span> </h3><h3></h3><h3><span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">Accountabilities:  </span></h3><ul><li><h3><span>Provides <span>clinical trial reporting </span><span>expertise</span><span> and leadership in support of global development programs as well as post-marketing registration and non-registration studies.</span></span> </h3></li></ul><ul><li><h3><span>Drives strategy with preferred vendors to ensure compliance <span>to</span><span> regulations and standards for associated technologies and development programs to ensure regulatory submission compliance.</span></span> </h3></li></ul><ul><li><h3><span>Partners </span><span>with Data Configuration Engineer, and Clinical Data Standards teams in the development of </span><span>s</span><span>tandard and study specific data cleaning/quality checks, study status metrics, </span><span>visualizations</span><span> and monitoring reports. </span> </h3></li></ul><ul><li><h3><span>Organizes Clinical Trial Reporting activities for assigned clinical studies and non-clinical data cleaning activities</span> </h3></li></ul><ul><li><h3><span>Foster and ensure close collaboration with study team</span><span> members (</span><span>e.g., EDC Developers</span><span>, Data Configuration engineer, </span><span>Clinical</span> <span>O</span><span>perations</span><span>, Clinical Data Managers, Statistical Programmers, </span><span>Statisticians</span><span> and other stakeholders) in the clinical data lifecycle</span><span> and in the development <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">/maintenance/governance</span> of standard data review </span><span>objectives</span><span> and libraries</span> </h3></li></ul><ul><li><h3>Assists<span> with oversight of Functional Service Provider (FSP) resource allocation and strategic vendor partnerships to effectively deliver on internal and/or outsourced projects.</span> </h3></li></ul><ul><li><h3><span>Might be responsible for</span><span> direct line management of employees.</span> </h3></li></ul><ul><li><h3><span>Establishes and <span>maintains</span><span> productive partnerships within Clinical Data Operations & Standards (CDOS), functional leaders across R&D, and third-party service providers.</span></span> </h3></li></ul><ul><li><h3><span>Responsible<span> for the review, development, </span><span>maintenance</span><span> and optimization of processes to ensure that clinical trial reporting activities </span><span>are in compliance with</span><span> regulatory and company requirements</span></span> </h3></li></ul><ul><li><h3><span>Training and mentoring staff <span>on</span><span> key activities and processes.</span></span> </h3></li></ul><ul><li><h3><span>Recognizes development needs and identifies/creates development opportunities within team </span> </h3></li></ul><ul><li><h3><span>Supports the development of the <span>clinical trial reporting</span><span> talent base and </span><span>identifies</span><span> development needs within the area of responsibility </span></span> </h3></li></ul><ul><li><h3><span>Contribute to the <span>enablement of</span><span> technology strategies that support clinical program activities (e.g., Cross Function Data Review and Cleaning).</span></span> </h3></li></ul><ul><li><h3><span>Show influential strategic, execution and delivery leadership both within Takeda and outside of Takeda with vendors and partners.</span> </h3></li></ul><ul><li><h3><span>Participates in <span>oversight to Global Development Operations technology vendors to ensure that they meet regulatory requirements and on delivery of </span><span>accurate</span><span> and efficient solutions to support therapeutic area management of global development programs.</span></span> </h3></li></ul><ul><li><h3><span>Represent function during internal audits and regulatory inspection in collaboration with Quality Assurance and GCP & Operational Excellence organizations.</span> </h3></li></ul><ul><li><h3><span>Confirm archival and inspection readiness of clinical trial reporting Trial Master File (TMF) documents</span> </h3></li></ul><ul><li><h3>Ensure compliance with own Learning Curricula, corporate and/or <span>GxP</span><span> requirements.</span>  </h3></li></ul><h3></h3><h3><span>Education & Competencies</span></h3><h3></h3><ul><li><h3>BS/BA in a health-related, life science area or technology-related fields. </h3></li></ul><ul><li><h3><span>Minimum of <span>8</span><span>+ </span><span>years of</span><span> drug development experience.</span></span> </h3></li></ul><ul><li><h3><span>6<span>+ years of project management and leadership experience</span></span> </h3></li></ul><ul><li><h3><span>Previous<span> experience leading </span><span>programming teams</span><span> and influencing senior-level management and key stakeholders is a plus</span></span> </h3></li></ul><ul><li><h3><span>Experience in programming listings and/or visualizations with any of the following Veeva CDB, <span>Elluminate</span><span> and </span><span>JReview</span></span> </h3></li></ul><ul><li><h3><span>Knowledge of clinical database systems (Metadata Rave, Veeva<span>)</span><span> a</span><span>nd e</span><span>xperience with </span><span>any </span><span>of these languages</span><span>:  CQL</span><span>, SQL, SAS, R, Python</span></span> </h3></li></ul><ul><li><h3><span>Knowledge of data structures and data flow between clinical data management systems, vendor <span>devices,</span><span> and CDR. </span></span> </h3></li></ul><ul><li><h3><span>Experience with managing vendors and implementation clinical technologies: (e.g., <span>Elluminate</span><span>, Veeva CDB, </span><span>CluePoint</span><span>, </span><span>Jreview</span><span>, SAS, R, </span><span>RShiny</span><span>) </span></span> </h3></li></ul><ul><li><h3>Operational experience in pharmaceutical drug development with exposure to clinical development and data operations <span>required</span><span> for the reporting of clinical trial data (</span><span>e.g.</span><span> data review, regulatory submissions, safety updates, etc.) </span> </h3></li></ul><ul><li><h3>K<span>nowledge of FDA and ICH regulations and industry standards and quality control principles</span><span> as well as best practices related to computer system validation, electronic records and signatures and data privacy.</span> </h3></li></ul><ul><li><h3><span>Experience managing <span>cross functional</span><span> projects and developing successful partnerships within and across functional areas </span></span> </h3></li></ul><ul><li><h3><span>Strong communication<span> (written and oral), leadership, decision-making, influencing, negotiation, and project management skills </span></span> </h3></li></ul><h3></h3><h3>This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy</h3><h3></h3><h3><span> </span></h3><p></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span>Takeda Compensation and Benefits Summary</span></b></p><p style="text-align:inherit"></p><p style="text-align:left"><span><span>We understand compensation is </span><span>an important factor</span><span> as you consider the next step in your career. We are committed to </span><span>equitable</span><span> pay for all employees, and we strive to be more transparent with our pay practices.</span></span><span> </span></p><p style="text-align:inherit"></p><p style="text-align:left"><b>For Location:</b></p>Massachusetts - Virtual<p style="text-align:inherit"></p><p style="text-align:left"><b><span><span>U.S. Base Salary Range:</span></span></b></p>$154,400.00 - $242,550.00<p><br>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. </p><p></p><p>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. </p><p></p><p style="text-align:inherit"></p><p style="text-align:left"><b><u>EEO Statement</u></b></p><p style="text-align:left"><i>Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.</i></p><p style="text-align:inherit"></p><h2><b>Locations</b></h2>Massachusetts - Virtual<p style="text-align:inherit"></p><h2><b>Worker Type</b></h2>Employee<p style="text-align:inherit"></p><h2><b>Worker Sub-Type</b></h2>Regular<p style="text-align:inherit"></p><h2><b>Time Type</b></h2>Full time<p style="text-align:inherit"></p><p style="text-align:left"><b>Job Exempt</b></p>Yes<p style="text-align:inherit"></p><p style="text-align:inherit"></p>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.