Operations Project Lead, Trial Operations Data - Alta Petens
Company: Takeda Pharmaceutical
Location: Bronx
Posted on: May 13, 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 Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
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.
T he Project Lead, Trial Operations Data is responsible for leading
projects related to 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 and automated
data quality checks, and enablement of disruptive technologies for
next-gen trial op erations 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 t rial operations data and will be inclusive of
all Takeda therapeutic areas and relevant business units.
DELIVERY & BUSINESS ACCOUNTABILITIES :
The Project Lead, Trial Operations Data is expected to:
Manage the trial operations data transformation for clinical trial
management system(s) to support Takeda R&D's vision to create a
development engine and ecosystem that provides optimal operational
data control and quality in a predictable, automated &
cost-effective way
Help lead multi-faceted business process mapping to inform
future-state trial operations 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
Support the selection and implementation of trial operations 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
Lead the clinical trial management system(s) data transformation
team and serve as a key representative for the operational data
ecosystem
Engage with stakeholders for all systems, data models and tools
within operational 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
analyst teams.
CORE ELEMENTS RELATED TO THIS ROLE:
Strategic Planning and Execution:
Helps develop and reach trial operations 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 operational data
team
Proactively identifies project issues before they arise and
develops contingency plans; communicates project-related issues to
Trial Operations Data Lead
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
trial management systems/operational data projects
DIMENSIONS AND ASPECTS:
Technical/Functional (Line) Expertise :
Executes R&D leadership with background in clinical trial
execution and operational 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
trial operational 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 collaborates 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
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 with identifying and implementing organization-wide
initiatives, standards, and processes
Experience within clinical trial execution and clinical trial
lifecycle
Strong experience in process development management, inspection
readiness, and clinical trial systems such as TMF and CTMS;
Experience with Veeva Vault Clinical Platforms desired
Solid understanding of system development lifecycle requirements
and of US CFR, GCP and ICH
Experience working in Cloud Computing environments (ex AWS, Azure,
etc.)
Strong leadership skills with wide range of global R&D
stakeholders
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, New Rochelle , Operations Project Lead, Trial Operations Data - Alta Petens, Other , Bronx, New York
Click
here to apply!
|