Associate Director, Data Quality System Testing Expert - Remote US

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Job Description

Takeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the R&D headquarters.

Clinical Data Sciences (CDS) at Takeda:

Key to Takeda’s success, the Clinical Data Sciences team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. The Clinical Data Sciences group is responsible for integrating structured and unstructured data across the various data sources, setup, data transfer/review and support downstream transformation and analysis.

Clinical Data Sciences is comprised of the Clinical Data Engineering and Clinical Data Standards teams. The Clinical Data Standards team provides the standards for clinical data operation and ensures consistency to standards in Takeda’s, and the Clinical Data Engineering team drives the data architecture for clinical data. Clinical Data Standards provides study level support for independent user acceptance testing to ensure study databases meet quality thresholds and adhere to the protocol and Takeda standards.

Associate Director, Clinical Data Quality Systems Testing Expert, Clinical Data Sciences (CDS) – Remote US:

Key to Takeda’s success is the Associate Director, Data Quality Systems Testing team. The Data Quality Systems Testing team provides strategic testing capabilities to ensure study database and standards build activities are delivered with quality and in a compliant manner. The Data Quality Systems Testing team leads the user acceptance activities associated with study database build across all therapeutic areas and in support of clinical data standards testing. The team also imagines innovative ways to automate testing in order to optimize adherence to Takeda’s clinical data standards as well as the delivery of high quality and timely study build.

Within Clinical Data Sciences, the Clinical Database builders and testers will verify that the study data collection system is based on approved build specifications and in alignment with the study protocol and Takeda clinical data standards. The Clinical Data Quality Systems Testing team will be responsible for generating user acceptance testing scripts and evidence that the electronic data capture (EDC) functions as per specifications and in alignment with Takeda clinical data standards.

Key Accountabilities:

• Performs user acceptance and/ or validation of clinical database build tasks according to applicable SOPs (standard operating procedures) and processes.

• Drive study database user acceptance testing activities in an individual contributor role that requires leadership across multiple therapeutic areas and the ability to partner closely with internal/external stakeholders to ensure the quality of the study build in the EDC system.

• Collaborate with various vendors and cross functional teams to build to ensure accuracy of any integration.

• Ensure accurate delivery of study build with quality deliverables per specification. Participate in the development, maintenance and training rendered on activities around study build and best practices used by business.

• Network with key business stakeholders on refining and enhancing the activities around study to automate the study build and reduce the need for testing.

• Develop organizational knowledge of organizational clinical data standards, key data sources, systems and be a valuable resource to people in the company on how to effectively automate study build to pursue company objectives. Provides technical leadership on various aspects of clinical data flow including build APIs to various systems for data extraction and integration.

• Performs user acceptance testing for data checks, core setup, and/or supports processes for various peripheral systems.

• Performs user acceptance and/ or validation of clinical database build tasks according to applicable SOPs (standard operating procedures) and processes.

• Drive study database user acceptance testing activities in an individual contributor role that requires leadership across multiple therapeutic areas and the ability to partner closely with internal/external stakeholders to ensure the quality of the study build in the EDC system.

• Collaborate with various vendors and cross functional teams to build to ensure accuracy of any integration.

• Ensure accurate delivery of study build with quality deliverables per specification. Participate in the development, maintenance and training rendered on activities around study build and best practices used by business.

• Network with key business stakeholders on refining and enhancing the activities around study to automate the study build and reduce the need for testing.

• Develop organizational knowledge of organizational clinical data standards, key data sources, systems and be a valuable resource to people in the company on how to effectively automate study build to pursue company objectives. Provides technical leadership on various aspects of clinical data flow including build APIs to various systems for data extraction and integration.

• Performs user acceptance testing for data checks, core setup, and/or supports processes for various peripheral systems.

• Coordinates the activities of external vendor personnel that might assist in testing to ensure all jobs are carried out and timelines are met.

• Provides basic technical support / consultancy, end-user support, works with IT in troubleshooting, reporting, and resolving system issues.

• Actively communicate with the management team and clinical teams regarding testing activities. Participate in frequent teleconferences and emails with clinical research institutions and vendor partners. Demonstrate diplomacy and patience in working to achieve common goals.

Additional Activities

• Assists with quality review of above activities performed by and external vendor, as needed.

• Adhere to SOPs for computer system validation and all health authority, ICH (International Council for Harmonization) GCP (Good Clinical Practice) regulations.

• Ensure compliance with own Learning Curricula, corporate and/or GxP requirements.

• Performs other duties as assigned within timelines

Educational Qualification:

• Bachelor's degree in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job.

Experience:

• MS with ~8 years experience or BS with ~10 years experience.

• Minimum of 5 years’ experience in clinical data collection instruments or similar applications in a programming or administration capacity.

• Knowledge of at least one clinical data management system and/or working knowledge of programming language.

• Must understand database concepts. Knowledge of XML, ALS and MDR preferred.

• Strong working knowledge of clinical trial terminology and Architect Loader Specification expected.

• Demonstrated ability to lead 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. Strong knowledge of MS Word, Excel, PowerPoint, Access, and Outlook.

• 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 learning new technologies and systems.

• Good knowledge of office software (Microsoft Office).

Behavioral Competencies:

• Is comfortable with ambiguity.

• Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills.

Job Complexity:

• Low-Medium complexity project.

• Occasional domestic/international travel to other Takeda sites, strategic partners, and therapeutic area events may be required.

Supervision:

• Supervision required, should be able to function collaboratively (with guidance) with all levels of employees.

License/Certifications:

• Preferred to have Rave Study Builder Certification.

Physical Demands:

• Ability to sit and stand for long periods of time.

• Carrying, handling, and reaching for objects.

• Manual dexterity to operate office equipment i.e. computers, phones, etc.

Travel Requirements:

• Requires approximately 1-2 domestic trips annually and up to 1 international trip.

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.

Base Salary Range: $143,500 to $205,000 based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

This position is currently classified as “Remote” in accordance with Takeda’s Hybrid and Remote Work policy.

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.

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