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Project Lead, Clinical Data - Alta Petens

Company: Takeda Pharmaceutical
Location: North Bergen
Posted on: May 9, 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
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.


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.


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


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.

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


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.

Cambridge, MA

Worker Type
Worker Sub-Type
Time Type
Full time

Keywords: Takeda Pharmaceutical, North Bergen , Project Lead, Clinical Data - Alta Petens, Healthcare , North Bergen, New Jersey

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