Project Lead, Clinical Data - Alta Petens
Company: Takeda Pharmaceutical
Location: Bronx
Posted on: June 22, 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 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 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 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 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
neededDIMENSIONS AND ASPECTS:Technical/Functional (Line) Expertise:
- Background in clinical trial execution and clinical 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
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 executionInteraction:
- 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 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 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-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, New Rochelle , Project Lead, Clinical Data - Alta Petens, Healthcare , Bronx, New York
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