Clinical Data Engineer (Sr. Manager) - Alta Petens
Company: Takeda Pharmaceutical
Posted on: November 25, 2022
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to the best of my knowledge.Job DescriptionTakeda 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. The Clinical Data Sciences comprises
of the Clinical Data Engineering 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. Clinical Data Engineer (CDE),
Clinical Data Sciences (CDS): Key to Takeda's success is the
Clinical Data Engineering team, provides strategic planning,
integrating, execution, build and oversight of clinical trial
deliverables. CDE leads the integration of collected data from all
sources, along with completion of clinical trial data deliverables
from study start-up through database lock and beyond. Under the
guidance of Clinical Data Sciences, the Clinical Data Engineer
architects and maintains the construct of the common data model
that ensures data ingestion for all study-level data capture
technologies and other related vendor and/or applications (e.g.,
EDC, IRT, ePRO, eCOA). Coordinates cross functionally, facilitates
test data transfer and confirms accurate DTA specification.
Performs tasks to build, maintain, and monitor data flow
integration between collected data and the clinical data repository
(CDR) alongside processing specialty data for exploratory analysis.
CDE contributes to the successful conduct of Takeda's clinical
trials and to the delivery of high quality in a timely manner,
which is eventually used for statistical analysis and submitted to
regulatory authorities for the approval of Takeda
products.---Further, CDE efforts enable valid secondary use of
clinical trial data throughout Takeda research groups to maximize
value and achieve company objectives. Key Accountabilities:
- Performs clinical data engineering tasks according to
applicable SOPs (standard operating procedures) and processes.
- Drive External data transfer in an individual contributor role
that requires data engineering leadership for clinical data
collection across multiple data sources and the ability to partner
closely with internal/external stakeholders in a collaborative
- Collaborate with various vendors and cross functional teams to
build and align on data transfer specification and ensure a
streamlined process of data integration.
- Ensure accurate delivery of data format and data frequency with
quality deliverables per specification.
- Participate in the development, maintenance and training
rendered by standards and other functions on transfer specs and
best practices used by business.
- Network with key business stakeholders on refining and
enhancing the integration of structured and non-structured
- Develop organizational knowledge of key data sources, systems
and be a valuable resource to people in the company on how to best
integrate data to pursue company objectives.
- Provides technical leadership on various aspects of clinical
data flow including assisting with the definition, build, and
validation of application program interfaces (APIs) to various
systems for data extraction and integration.
- Coordinates with data base builders and data management (DM)
programmers ensuring accuracy of data integration per SOPs.
- Provide basic technical support / consultancy and end-user
support, work with Information Technology (IT) in troubleshooting,
reporting, and resolving system issues.
- Develop and deliver training programs to internal and external
team, ensure timely communication of new and/or revised data
transfer specs. Additional Activities:---
- Assists with quality review of above activities performed by a
vendor, as needed.
- Assess and enable clinical data visualization software---in the
- Adhere to SOPs for computer system validation and all GCP (Good
Clinical Practice) regulations.
- Ensure compliance with own Learning Curricula, corporate and/or
- Performs other duties as assigned within timelines Educational
- 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:
- BS with -7+ years of relevant experience. Experience in
clinical data engineering or similar in data integration across
multiple sources including collected data and CDR alongside
processing specialty data for exploratory analysis. Graduate degree
- Knowledge of data flow between clinical data management
systems, vendor devices and CDR.
- Must understand database concepts. Knowledge of XML, ALS, APIs
and MDR preferred.
- Strong working knowledge of clinical trial terminology and data
transfer specification expected.
- Proven ability to manage and communicate effectively with
service providers including Budgeting, forecasting, negotiating
contracts, reviewing request for proposals, analyzing scope of
work, responding to inquiries and complaints.
- 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 asking questions, learning new
technologies and systems---
- Good knowledge of office software (Microsoft Office).---
- Is comfortable with ambiguity.---
- Excellent teamwork, organizational, interpersonal, conflict
resolution and problem-solving skills.--- --- Job Complexity:
- Medium-High complexity project.---
- Occasional domestic/international travel to other Takeda sites,
strategic partners, and therapeutic area events may be required.---
- Supervision required, should be able to function
collaboratively (with guidance) with all levels of employees.---
- Preferred to have SAS or R or Python certification,--- Physical
- 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.--- WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution
- Tuition reimbursement Company match of charitable
- Health & Wellness programs including onsite flu shots and
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach ProgramsDiscover more at takedajobs.comNo
Phone Calls or Recruiters Please.#LI-KD1 ---This position is
currently classified as "hybrid" in accordance with Takeda's Hybrid
and Remote Work policy.Base Salary Range: $130,200.00 to
$186,000.00, 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. EEO
StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Newark , Clinical Data Engineer (Sr. Manager) - Alta Petens, Engineering , Newark, New Jersey
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