Project Lead, Clinical Data - Alta Petens
Company: Takeda Pharmaceutical
Location: North Bergen
Posted on: May 9, 2022
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Job Description:
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to the best of my knowledge.
Job Description
OBJECTIVES/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 co ntrol 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 groups
Leverage 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 team
Proactively 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
projects
Work closely with the management team to execute the work and
maintain intercollaborative communication with external teams, as
needed
DIMENSIONS 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&D
Seeks 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
field
Experience 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-KD1
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.
EEO Statement
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.
Locations
Cambridge, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, North Bergen , Project Lead, Clinical Data - Alta Petens, Healthcare , North Bergen, New Jersey
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