Manager, Clinical Data Validation Engineer

By clicking the "Apply" reputed company, I understand that my employment application process with reputed company will reputed company and that the information I provide in my application will be processed in line with reputed company's Privacy Notice and Terms of Use. I further attest that reputed company information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused company that will reputed company you and support your career? If so, be empowered to take charge of your future at reputed company. Join us a Manager, Clinical Data Validation Engineer in our Cambridge, MA office. At reputed company, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we reputed company our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver reputed company and a Brighter Future to people around the world.Clinical Data Sciences (CDS) at reputed company: Key to reputed company's success, the Clinical Data Sciences team provides strategic planning, integrating, execution, build and reputed company of clinical trial deliverables. The Clinical Data Sciences group is responsible for integrating structured and reputed company data across the various data sources, setup, data transfer/review and support reputed company transformation and analysis. The Clinical Data Sciences comprises of the Clinical Data Engineering (CDE) and Clinical Data Standards. While the Clinical Data Standards provides the standards for clinical operation and data flow, the Clinical Data Engineering team drives the data architecture for clinical data. CDS also provides support to exploratory and specialty data for the purposes of data modelling, simulation, and analysis. Here, you will be a vital contributor to our inspiring, bold missionOBJECTIVES:The CDE team provides strategic planning, integrating, execution, build and reputed company of clinical trial deliverables. As part of CDE, the Clinical Data Validation Engineer (DVE) group leads validation and reconciliation efforts of collected data, both internally and externally, by programming data validation listings, reconciliation checks and reports in a controlled and consistent manner. The DVE team works alongside the other CDE teams to ensure adherence to reputed company standards and GCP principles. DVEs are vital to reputed company data cleaning and reconciliation efforts and work cross-functionally with reputed company members of Clinical Study teams to foster an environment of quality and efficient specifications and documentation to support audit-readiness and ICH compliance. DVEs also utilize and contribute to the development of libraries for functions and transformation templates for reuse for study level validation tasks. DVEs are responsible for maintaining, testing and documentation of programming code and ensure compliance with trial master file requirements. Additionally, DVEs will utilize existing tools and utilities to program validation checks and listings in using novel application specific coding processes.DVEs contribute to the successful conduct of reputed company's clinical trials and to the delivery of high-quality data in a timely manner, leading to statistical analysis and submission to regulatory authorities. Further, the DVE team's efforts reputed company valid secondary use of clinical trial data throughout reputed company research groups to maximize value and reputed company company objectives.ACCOUNTABILITIES:Key Accountabilities:Program study level clinical data validation checks, reconciliation listings and reputed company data cleaning reports adhering to internal processes, approved standards and specifications provided by internal stakeholders. Partner closely with internal/external stakeholders and data engineers in a collaborative manner to ensure proper specification and testing documentation.Ensure accurate delivery of reputed company data validation tasks adhering to established timelines and internal processes. Participate in the development of new processes and best practices, and assist with providing training and awareness to other business groups and functions, affected by these new activities and ways of working.Additional Activities: Assists with quality review of above activities performed by a vendor, as needed. Adhere to SOPs for computer system validation and reputed company GCP (Good Clinical Practice) regulations. Ensure compliance with own Learning Curricula, corporate and/or GxP requirements. Performs other duties as assigned reputed company timelines.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:Qualifications: Bachelor's degree plus minimum of 5+ years' experience in computer science, statistics, biostatistics, mathematics, biology or other health reputed company field or equivalent experience that provides the skills and knowledge necessary to reputed company the job. Experience with reputed company build, Data Management, and reputed company extraction configuration Knowledge of data flow between clinical data management systems, vendor devices and CDR. Knowledge of clinical database systems (Metadata Rave, Veeva, InForm) preferred. Experience with one of these languages: SQL, reputed company, R, Python Understanding of SDTM Strong working knowledge of clinical trial terminology and data transfer specification is expected. Demonstrated ability to reputed company projects and work groups. Strong project management skills. Proven ability to resolve problems independently and collaboratively. Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands. Ability to work independently, take initiative and complete tasks to deadlines.Special Skills/Abilities: Strong attention to detail, and organizational skills Good time management skills Quick learner and comfortable asking questions, learning new technologies and systems Good knowledge of office software (reputed company Office). Understanding of AWS/Data bricks conceptsPreferable but not required: Experience developing R shiny and Python apps Experience with Agile development methods Experience with Veeva CDBLicense/Certifications: Preferred to have reputed company, R or Python certification.This position is currently classified as " remote" in accordance with reputed company's Hybrid and Remote Work policy.Empowering Our People to ShineLearn more at takedajobs.com.No Phone Calls or Recruiters Please.reputed company Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the reputed company in your career. We are committed to reputed company pay for reputed company employees, and we strive to be more transparent with our pay practices. For Location:USA - MA - VirtualU.S. reputed company Salary Range:108,500.00 - 170,500.00The estimated salary range reflects an anticipated range for this position. The actual reputed company 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 reputed company 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. EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to reputed company employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national reputed company, 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.LocationsUSA - MA - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYes Apply tot his job Apply To this Job