Clinical Data Lead - Alta Petens
Company: Takeda Pharmaceutical
Posted on: May 9, 2022
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Are you looking for a patient-focused, innovation-driven company
that will inspire you and empower you to shine? Join us as a
Clinical Lead - Alta Petens in our Cambridge office!
At Takeda, we are transforming the pharmaceutical industry through
our R&D-driven market leadership and being a values-led
company. To do this, we empower our people to realize their
potential through life-changing work. Certified as a Global Top
Employer, we offer stimulating careers, encourage innovation, and
strive for excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our global teams are united by an
unwavering commitment to deliver - Better Health and a Brighter
Future -to people around the world.
Here, you will be a vital contributor to our inspiring, bold
Takeda is advancing an exciting pipeline and wants to ensure that
we have the infrastructure and talent in place to support it. Our
overall goal is to ensure that we get our therapeutics to patients
quickly by having the right operational model and integrated
clinical data pipeline to support delivery.
The Clinical Data Lead is responsible for leading the systems,
process, and governance transformation for clinical trial data as
part of a transformational data program. This data program will
include an integrated data flow with end-to end control of data,
internalization of numerous systems and processes, broad enablement
of automation and near-time data access, efficient data review and
query, and enablement of disruptive technologies for next-gen trial
designs and insights. - The data program will encompass all
systems, platforms and tools involved in the collection,
processing, review, analysis, and downstream reporting or
consumption of clinical trial data and will be inclusive of all
Takeda therapeutic areas and relevant business units. You will
report to our Head of Systems and Architecture.
Delivery & Business Accountabilities
The Clinical Data Lead is expected to:
Lead the clinical data transformation to support Takeda R&D's
vision to create a development engine and ecosystem that provides
optimal clinical data control and quality in a predictable,
automated & cost-effective way
Lead multi-faceted business process mapping to inform future-state
clinical data flow and system and architecture design; Work with
other leaders to ensure business impact is well-understood and
accounted for within broader future fit development workstreams
Lead the selection and implementation of clinical data vendors,
systems, platforms, and tools to support a transformed global data
Define and embed appropriate quality oversight and governance tools
and processes throughout data program in accordance with R&D
Oversee or manage key resources working on the operational data
transformation team and/or operational data ecosystem
Oversee or manage key resources working on the clinical data
transformation team and/or clinical data ecosystem
Engage and direct product owners and other supporting roles for all
systems, data models and tools within clinical data ecosystem
In collaboration with other leaders, create and manage transition
plans from former state to transformed state and lead or contribute
to future-state processes
Show influential strategic, execution and delivery leadership both
within Takeda and outside of Takeda with vendors and partners
Provide strategic vision for long-term delivery innovation
CORE ELEMENTS RELATED TO THIS ROLE
Strategic Planning and Execution
Leads in setting clinical data goals, priorities, plans and
schedules. Aligns and coordinates with corresponding workstreams
Visibly engages across the organization to ensure transformational
Monitor and control expenditures; manages variance between budgeted
and actual expenditures of time, dollars, and personnel while
meeting overall Takeda financial objectives.
Resource and Issue Management
Manages internal and external resources (people, information,
technologies, time, and
Proactively identifies project issues before they arise and
develops contingency plans; communicates project-related issues to
senior executive management and manages issues to resolution.
Supports strategies for effecting change, controlling change and
helping people to adapt to change.
Matrix Team Management
Provides matrix management, strategic and tactical leadership
across data program.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
PhD with 8-12+ years experience, or MS with 12-15 years experience
-in data management and/or database or statistical programming
experience in pharmaceutical industry or health related field.
Proven track record in identifying and implementing
organization-wide initiatives, standards, and processes.
In-depth knowledge of data management systems and processes,
analysis and reporting principles.
Strong understanding of the development and management of a
Good knowledge of statistical programming languages (e.g. SAS) and
statistical compute environments
Technical expertise (e.g. Windows NT and UNIX operating systems)
and familiarity with common software products and technologies used
in conjunction with SAS.
Expertise in the requirements and technology required to support
electronic data capture and electronic submissions.
Knowledge of medical and statistical -terminology. -Comprehensive
-understanding of pharmaceutical standard initiatives such as CDISC
(ADaM, SDTM, CDASH and ODM), HL7, etc.
Strong understanding -of system development lifecycle requirements
-and -of US CFR, GCP and ICH
Experience working in Cloud Computing environments (ex AWS, Azure,
Tolerance of ambiguity and willingness to work through complex
Ability to work with global internal and external partners to
achieve desired goals
Ability to develop solutions to complex issues and challenges
Promotes teamwork while working through solutions
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.
In accordance with the CO Equal Pay Act, -Colorado Applicants Are
Not Permitted to Apply.
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.
Keywords: Takeda Pharmaceutical, Malden , Clinical Data Lead - Alta Petens, Healthcare , Malden, Massachusetts
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