Project Lead, Clinical Data - Alta Petens
Company: Takeda
Location: Somerville
Posted on: June 17, 2022
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Job Description:
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application process with Takeda will commence and that the
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with Takeda's Privacy Noticeand Terms of Use. I further attest that
all information I submit in my employment application is true to
the best of my knowledge.Job DescriptionOBJECTIVES/PURPOSE:Takeda
is advancing an exciting product pipeline and wants to ensure that
we have the infrastructure and talent in place to support it. Our
overall goal is to get our therapeutics to patients safely and
quickly via an optimized operational model and integrated clinical
data pipeline.The Clinical Data Project Lead is responsible for
leading projects related to the clinical data pipelines, systems,
processes, and governance part of a transformational clinical data
program. The clinical 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. - -Multiple Project Leads will be hired to lead and
collaborate on projects. - Projects will include Protocol
Digitization; Electronic Data Capture Systems; Data Integration,
Review and Query Platforms; Data Visualizations; Complex Data
Pipelines and other technology projects related to end-to-end
clinical data flow.DELIVERY & BUSINESS ACCOUNTABILITY:The Clinical
Data Project Lead is expected to:Lead specific projects in 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 - -Help 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 program -Help define and embed
appropriate quality oversight and governance tools and processes
throughout data program in accordance with R&D policies -Engage
with stakeholders for all systems, data models and tools within
clinical data ecosystem -Help facilitate the transition plans from
former state to transformed state and contribute to future-state
processes -Serve as a leader within Takeda and outside of Takeda
with vendors and partners -Help shape the strategic vision for
long-term delivery innovation -Communicate challenges and successes
within project groupsLeverage strong leadership and interpersonal
skills in managing delivery/analyst teams.CORE ELEMENTS RELATED TO
THIS ROLE:Strategic Planning and Execution:Helps develop and reach
clinical data goals, priorities, plans and schedules.Engages with
leadership and analysis teams to ensure transformational impact -
-Fiscal Responsibility:Manages and reports expenditures, being
cognizant of variance between budgeted and actual expenditures of
time, dollars, and personnel while meeting overall Takeda financial
objectives. -Resource and Issue Management:Helps manage internal
and external resources (people, information, technologies, time,
and -capital) within the clinical data teamProactively identifies
project issues before they arise and develops contingency plans;
-communicates project-related issues to Clinical Data Lead to
resolution. -Change Management:Supports strategies for effecting
change, controlling change, and helping people to adapt to change.
-Matrix Team Management:Provides strategic and tactical leadership
across the clinical data projectsWork closely with the management
team to execute the work and maintain intercollaborative
communication with external teams, as neededDIMENSIONS AND
ASPECTS:Technical/Functional (Line) Expertise:Background in
clinical trial execution and clinical data systems, processes and
reporting -Leadership:Inspires, motivates and drives results
-Communicates clearly, persuasively conveying both ideas and data,
verbally and in writing - -Decision-making and Autonomy:Provides
input to highly complex decisions that impact overall clinical data
management and R&DSeeks diverse input from multiple
constituents and stakeholders to drive innovative solutions
-Incorporates feedback and ensure decisions are implemented swiftly
to yield flawless execution - - -Interaction:Effectively represents
program in negotiations with the ability to resolve conflict in a
constructive manner -Builds strong relationships and collaborate
effectively with other interfacing Takeda functions
-Innovation:Recommends, influences and implements organizational
change and continuous innovation -Identifies opportunities and
anticipates changes in the business landscape through an
understanding and ongoing assessment of the environment affecting
the business. -Serves as a role model, demonstrating respect and
inclusion, creating a culture that fosters innovation
-Complexity:Works in a global ecosystem (internal and external)
with a high degree of complexity -Recognizes broad, enterprise
level perspective - - -To succeed, the role requires deep
understanding of clinical development processes and - exceptional
attention to detail.EDUCATION, BEHAVIOURAL COMPETENCIES AND
SKILLS:Advanced degree with 7+ years experience---in data-related
field and experience in pharmaceutical industry or health related
fieldExperience in pharmaceutical industry or health related field.
- -Experience with identifying and implementing organization-wide
initiatives, standards, and processes.--- -Knowledge of data
management systems and processes, analysis and reporting
principles.--- -Knowledge of programming languages (e.g. SAS, R,
Python) and analytics environments -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, etc) -Tolerance of
ambiguity and willingness to work through complex issues---
-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--- - -#LI-KD1This 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.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.LocationsCambridge,
MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda, Somerville , Project Lead, Clinical Data - Alta Petens, Healthcare , Somerville, Massachusetts
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