Operations Project Lead, Trial Operations Data - Alta Petens
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 13, 2022
Job Description:
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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 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 operations 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 trial 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 impactFiscal 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 LeadChange 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 projectsDIMENSIONS AND
ASPECTS:Technical/Functional (Line) Expertise:
- Executes R&D leadership with background in clinical trial
execution and operational data systems, processes and
reportingLeadership:
- Inspires, motivates and drives results
- Communicates clearly, persuasively conveying both ideas and
data, verbally and in writingDecision-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 executionInteraction:
- 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 functionsInnovation:
- 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 innovationComplexity:
- Works in a global ecosystem (internal and external) with a high
degree of complexity
- Recognizes broad, enterprise level perspectiveEDUCATION,
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-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 Pharmaceutical, Cherry Hill , Operations Project Lead, Trial Operations Data - Alta Petens, Other , Cherry Hill, New Jersey
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