Clinical Data Lead - Alta Petens
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 8, 2022
Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAre 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 mission.OBJECTIVES/PURPOSE
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
program
- Define and embed appropriate quality oversight and governance
tools and processes throughout data program in accordance with
R&D policies
- 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 innovationCORE
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
and initiatives.
- Visibly engages across the organization to ensure
transformational impactFiscal Responsibility
- 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.Change
Management
- 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
standards library. -
- 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, 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.LocationsBoston, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Cherry Hill , Clinical Data Lead - Alta Petens, Healthcare , Cherry Hill, New Jersey
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