Project Lead, Clinical Data - Alta Petens
Company: Takeda Pharmaceutical
Location: Clifton
Posted on: January 19, 2023
Job Description:
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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
Base Salary Range: $160,300 Range Min to $229,000 Range Mid, based
on candidate professional experience level. Employees may also be
eligible for Short Term and Long-Term Incentive benefits as well.
Employees are eligible to participate in Medical, Dental, Vision,
Life Insurance, 401(k), Charitable Contribution Match, Holidays,
Personal Days & Vacation, Tuition Reimbursement Program and Paid
Volunteer Time Off.
The final salary offered for this position may take into account a
number of factors including, but not limited to, location, skills,
education, and experience.
This position is currently classified as "remote" in accordance
with Takeda's Hybrid and Remote Work policy.
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, Clifton , Project Lead, Clinical Data - Alta Petens, Healthcare , Clifton, New Jersey
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