Sr. Manager, Clinical Data Standards/ Operations & Study Support - Remote US
Company: Takeda Pharmaceutical
Posted on: September 17, 2022
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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 Takedas 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 worlds 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 Takedas success, the Clinical Data Sciences team provides
strategic planning, integration, 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
supporting 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 Takedas data flow, and the Clinical Data Engineering
team drives the data architecture for clinical data. Clinical Data
Standards also provide support to exploratory and specialty data
for the purposes of data modeling, simulation, and
analysis.Clinical Data Standards Operations and Study support Lead,
Data Science Institute (DSI): Key to Takedas success is the
Clinical Data Standards team. The Clinical Data Standards
Governance team provides strategic planning, integration,
execution, build and oversight of clinical data standards
deliverables. Leads the governance of clinical data standards
across all therapeutic areas along the clinical data value chain.
The Clinical Data Standards team creates innovative ways to
optimize standards deliverables to reduce timelines from protocol
finalization to submission.Within Clinical Data Sciences, the
Clinical Data Standards Operations and study team leads all
activities to support clinical study operations. You will be a
member of Takedas dedicated and highly effective Clinical Data
Standards team in Data Science organization. You will provide
leadership in the planning and execution of Takedas clinical
Research supporting the clinical data standards process. You will
ensure the efficient and collaborative conduct of Standards
governance processes for Data Standards governance boards, and for
monitoring the operational effectiveness of the committees and
boards through regular monitoring and analysis of operational
metrics. You will succeed by developing and maintaining
collaborative partnerships with other functional and TAU heads.As
an advisor and an expert, you will be able to build and leverage
constructive relationships across the organization to achieve
Clinical Data Standards goals and objectives. You will be entrusted
with driving data-driven excellence through our governance
processes to benefit Takedas portfolio of products and projects.
Through your expertise and extensive knowledge, you will be able to
foster a culture that promotes innovation and thrives on doing
better for patients and healthcare.Key Accountabilities:
- Support study requests, follow standards processes for study
request triage and progression to completion within customer
requested time frame
- Collaboration within the standards team and also wider with
study teams and cross-functionally and therapeutically
- Support individual requests and follow Standards SOPs to build
Global and TA level standards
- Leads or contributes to the development and maintenance of
Clinical Data Standards models (including but not limited to:
CDASH, SDTM, Controlled Terminology, TFLs and questionnaires).
Includes periodic assessment of standards content with respect to
compliance and industry impacts.
- Leads the development and maintenance of project plans and
effectively articulates them; defines risks and recommends
- Leads standards compliance review and works with functional
areas and CROs/strategic service providers to reinforce content and
interpretation of Takeda standards
- Acts as Standards area project manager or team leader for
selected standards projects and teams.
- Develops strategy for Standards Management technology selection
and deployment across Clinical Studies in alignment with
established Takeda SOPs & Policies, and governance models.
- Performs other duties as assigned.
- Additional Activities
- Assists with quality review of the above activities performed
by an 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
- 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:
- Minimum of 5 years experience in clinical data collection
instruments or similar applications in a programming or
administration capacity. Minimum of 1-year experience with Medidata
Rave and/or Rave certification.
- 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.Special Skills/Abilities:
- 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).Behavioral
- 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
- Supervision required, should be able to function
collaboratively (with guidance) with all levels of
- Preferred to have Rave Study Builder 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, etcTravel Requirements:
- Requires approximately 1-2 domestic trips annually and up to 1
international trip.In accordance with the CO Equal Pay Act,Colorado
Applicants Are Not Permitted to Apply.Base Salary Range:
$130,200.00 - $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.This
posting is made in compliance with Colorados Equal Pay for Equal
Work Act, C.R.S. 8-5-101 et seq.This position is currently
classified as remote in accordance with Takedas Hybrid and Remote
Work policy.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.LocationsMassachusetts -
VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Brookline , Sr. Manager, Clinical Data Standards/ Operations & Study Support - Remote US, Healthcare , Brookline, Massachusetts
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