B
Associate Director, Data Validation Engineer
Accepting applicationsBioSpace · United States
Full-Time Senior Pythonaiarmasicate
Posted
1d ago
Category
Test
Experience
Senior
Country
United States
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Job Description
Objective / Purpose:ThisAssociate Director,Data Validation Engineer(DVE)rolewill work on Clinical Trial Reporting activities to deliver data listings and visualizations tofacilitatethe delivery of high-quality datain 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 willutilizeand contribute to the development of libraries for listings and visualizations including functions and transformation templates for reuse for study level validation tasks. DVEsare responsible formaintaining, testing and documentation of programming tasks andensuringcompliance with trial master file requirements.This roleoperatesin compliance with Takeda SOPs and processes while workingclosely withClinical Data Operations Functions and others to enhance existing processes.Accountabilities:
Providesclinical trial reportingexpertiseand leadership in support of global development programs as well as post-marketing registration and non-registration studies.
Drives strategy with preferred vendors to ensure compliancetoregulations and standards for associated technologies and development programs to ensure regulatory submission compliance.
Partnerswith Data Configuration Engineer, and Clinical Data Standards teams in the development ofstandard and study specific data cleaning/quality checks, study status metrics,visualizationsand monitoring reports.
Organizes ClinicalTrial Reporting activities for assigned clinical studies and non-clinical data cleaning activities
Foster and ensure close collaboration withstudy teammembers (e.g., EDC Developers, Data Configuration engineer,ClinicalOperations, Clinical Data Managers, Statistical Programmers,Statisticiansand other stakeholders) in the clinical data lifecycleand in the development /maintenance/governance of standard data reviewobjectivesand libraries
Assistswith oversight of Functional Service Provider (FSP) resource allocation and strategic vendor partnerships to effectively deliver on internal and/or outsourced projects.
Mightbe responsible fordirect line management of employees.
Establishes andmaintainsproductive partnerships within Clinical Data Operations & Standards (CDOS), functional leaders across R&D, and third-party service providers.
Responsiblefor the review, development,maintenanceand optimization of processes to ensure that clinical trial reporting activitiesare in compliance withregulatory and company requirements
Training and mentoring staffonkey activities and processes.
Recognizes development needs and identifies/creates development opportunities within team
Supports the development of theclinical trial reportingtalent base andidentifiesdevelopment needs within the area of responsibility
Contribute to theenablement oftechnology 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 inoversight to Global Development Operations technology vendors to ensure that they meet regulatory requirements and on delivery ofaccurateand 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/orGxPrequirements.
Education & Competencies
BS/BA in a health-related, life science area or technology-related fields.
Minimum of8+years ofdrug development experience.
6+ years of project management and leadership experience
Previousexperience leadingprogramming teamsand influencing senior-level management and key stakeholders is a plus
Experience in programming listings and/or visualizations with any of the following Veeva CDB,ElluminateandJReview
Knowledge of clinical database systems (Metadata Rave, Veeva)and experience withanyof these languages: CQL, SQL, SAS, R, Python
Knowledge of data structures and data flow between clinical data management systems, vendordevices,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 operationsrequiredfor 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 principlesas well as best practices related to computer system validation, electronic records and signatures and data privacy.
Experience managingcross functionalprojects 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.
EEO Statement
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.
LocationsMassachusetts - Virtual
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull 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.
Show more Show less
Job Description
Objective / Purpose:ThisAssociate Director,Data Validation Engineer(DVE)rolewill work on Clinical Trial Reporting activities to deliver data listings and visualizations tofacilitatethe delivery of high-quality datain 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 willutilizeand contribute to the development of libraries for listings and visualizations including functions and transformation templates for reuse for study level validation tasks. DVEsare responsible formaintaining, testing and documentation of programming tasks andensuringcompliance with trial master file requirements.This roleoperatesin compliance with Takeda SOPs and processes while workingclosely withClinical Data Operations Functions and others to enhance existing processes.Accountabilities:
Providesclinical trial reportingexpertiseand leadership in support of global development programs as well as post-marketing registration and non-registration studies.
Drives strategy with preferred vendors to ensure compliancetoregulations and standards for associated technologies and development programs to ensure regulatory submission compliance.
Partnerswith Data Configuration Engineer, and Clinical Data Standards teams in the development ofstandard and study specific data cleaning/quality checks, study status metrics,visualizationsand monitoring reports.
Organizes ClinicalTrial Reporting activities for assigned clinical studies and non-clinical data cleaning activities
Foster and ensure close collaboration withstudy teammembers (e.g., EDC Developers, Data Configuration engineer,ClinicalOperations, Clinical Data Managers, Statistical Programmers,Statisticiansand other stakeholders) in the clinical data lifecycleand in the development /maintenance/governance of standard data reviewobjectivesand libraries
Assistswith oversight of Functional Service Provider (FSP) resource allocation and strategic vendor partnerships to effectively deliver on internal and/or outsourced projects.
Mightbe responsible fordirect line management of employees.
Establishes andmaintainsproductive partnerships within Clinical Data Operations & Standards (CDOS), functional leaders across R&D, and third-party service providers.
Responsiblefor the review, development,maintenanceand optimization of processes to ensure that clinical trial reporting activitiesare in compliance withregulatory and company requirements
Training and mentoring staffonkey activities and processes.
Recognizes development needs and identifies/creates development opportunities within team
Supports the development of theclinical trial reportingtalent base andidentifiesdevelopment needs within the area of responsibility
Contribute to theenablement oftechnology 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 inoversight to Global Development Operations technology vendors to ensure that they meet regulatory requirements and on delivery ofaccurateand 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/orGxPrequirements.
Education & Competencies
BS/BA in a health-related, life science area or technology-related fields.
Minimum of8+years ofdrug development experience.
6+ years of project management and leadership experience
Previousexperience leadingprogramming teamsand influencing senior-level management and key stakeholders is a plus
Experience in programming listings and/or visualizations with any of the following Veeva CDB,ElluminateandJReview
Knowledge of clinical database systems (Metadata Rave, Veeva)and experience withanyof these languages: CQL, SQL, SAS, R, Python
Knowledge of data structures and data flow between clinical data management systems, vendordevices,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 operationsrequiredfor 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 principlesas well as best practices related to computer system validation, electronic records and signatures and data privacy.
Experience managingcross functionalprojects 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.
EEO Statement
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.
LocationsMassachusetts - Virtual
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull 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.
Show more Show less