Sr. Manager, Clinical Data Standards/ Standards Data Governance - Remote US
Company: Takeda Pharmaceutical
Posted on: November 24, 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
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, 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 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 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 Governance Lead, Data Science Institute
(DSI): Key to Takeda's 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 Governance manager will lead the
governance team meetings and You will be a member of Takeda's
dedicated and highly effective Clinical Data Standards team in Data
Science organization. You will provide leadership in the planning
and execution of Takeda's 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 Takeda's 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:
- Apply your extensive knowledge of standards and drug
development and associated governance processes, leveraging
precedents, and in collaboration with the Governance Leader and the
Committee Chairs, you will monitor, develop and implement
streamlined processes for effective and timely data standard
development, review and approval.
- Engage in a "continuous improvement", innovation-focused
mindset in order to enhance the cross-functional governance and
- Provide project management leadership to Clinical Data
Standards Boards (CDSB), working directly with the chairs and data
standards team leads, facilitating meetings, offline reviews, and
document review decisions. Create and maintain governance agendas,
and track and coordinate review periods.
- Identify opportunities, develop and deploy tools and approaches
to correct and optimize areas of redundancy or weakness in existing
or proposed processes for cross-governance and data standards
- Using your broad cross-functional experience, evaluate the
content of review documentation and context of
meeting/communications to ensure effective interactions; work with
teams to resolve discrepancies/gaps/missing information to ensure
successful interaction with data standards governance.
- Develop and provide regular reports and recommendations to the
Governance Leaders and functional leadership to assess governance
body performance, make recommendations and implement corrective
action as appropriate.
- Working with Digital Data Technologies, create specifications
for the design and maintenance of governance management tools for
users to obtain information to enable efficient review and
- Lead and engage governance management and functional line
efforts to champion, develop and apply the robust and efficient
methodology to determine the impact of governance and oversight on
the efficiency of protocol design as it relates to data standards
- Routinely engage data standards governance and board members
directly to solicit feedback to ensure effective operations.
Incorporate observations as appropriate into operating
- Using experience and precedent, lead, collaborate and
effectively influence limited duration workstreams which are
working to enhance data-related processes.
- Challenge the status quo, promote innovation, and take
appropriate risks to drive improved outcomes.
- Bring your knowledge of current clinical data standards and
sufficient expertise to contribute to and influence discussions
pertaining to standards.
- In conjunction with the chairs of the CDSBs, coordinate and
lead global, cross-functional meetings/teleconferences (e.g.
defining requirements) to ensure adequate business and technical
review of complex issues raised regarding potential modification to
the clinical data standards.
- Baseline current process, develop metrics needed to assess the
ability of the clinical data standards governance bodies to manage
and mitigate change effectively; adopts an innovative, "continuous
improvement" approach to both process and outcomes.
- Provide clear and timely feedback and communications with study
teams and other customers who have open requests and assist them in
advancing to resolution as efficiently as practical to avoid any
delays to study timeline ---Additional Activities
- Assists with quality review of the above activities performed
by any 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.
- 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).
- 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 required, should be able to function
collaboratively (with guidance) with all levels of employees.
- Preferred to have CDISC accreditations. -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. -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
position is currently classified as "Remote" in accordance with
Takeda's 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, Rochester , Sr. Manager, Clinical Data Standards/ Standards Data Governance - Remote US, Healthcare , Rochester, New York
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