Manager/Sr Manager, Data Quality System Testing Expert - Remote US
Company: Takeda Pharmaceutical
Posted on: September 15, 2022
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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
Manager/Senior Manager, Clinical Data Quality Systems Testing
Expert, Clinical Data Sciences (CDS) - Remote US:
Key to Takeda s success is the 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.
- 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/ 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
- 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.
- 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
- Performs other duties as assigned within timelines.
- 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.
- Minimum of 5 years experience in clinical data collection
instruments or similar applications in a programming or
- 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
- 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.
- Strong attention to detail, and organizational skills
- Good time management skills
- Quick learner and comfortable learning new technologies and
- Good knowledge of office software (Microsoft Office).
- Is comfortable with ambiguity.
- Excellent teamwork, organizational, interpersonal, conflict
resolution and problem-solving skills.
- Low-Medium complexity project.
- Occasional domestic/international travel to other Takeda sites,
strategic partners, and therapeutic area events may be required
- Preferred to have Rave St udy Builder Certification.
- 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,
- Requires approximately 1-2 domestic trips annually and up to 1
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.
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
Base Salary Range: $102,000 to $146,000 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
This posting is made in compliance with Colorado s Equal Pay for
Equal Work Act, C.R.S. 8-5-101 et seq
T his position is currently classified as "remote" in accordance
with Takeda s Hybrid and Remote Work policy.
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Keywords: Takeda Pharmaceutical, Lynn , Manager/Sr Manager, Data Quality System Testing Expert - Remote US, Executive , Ipswich, Massachusetts
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