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Takeda Pharmaceutical Company Ltd Lexington, United StatesBy 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 subm ...
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Senior Manager, Clinical Data Management
2 weeks ago
Takeda Pharmaceutical Company Ltd Lexington, United StatesBy 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 subm ...
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Senior Manager, Clinical Data Management - Lexington, United States - Takeda
![Takeda background](https://contents.bebee.com/companies/us/takeda/background-2zayU.png)
Description
Senior Manager, Clinical Data ManagementAt Takeda, we exist to create better health for people and a brighter future for the world.
While we continually evolve science and technology, our ambition remains steadfast we move science forward so we can transform more lives.
The Global Development Office (GDO) maintains a laser focus on Study Management and Site Engagement, Clinical Trial Innovation, Clinical Supply Chain and Patient Safety to ensure absolute quality and enable the predictable delivery of our innovative pipeline.
Through its collaborative process, the GDO team leverages data, digital and analytics to improve speed, quality, performance and predictability within every area of clinical development.
Were building a platform to visualize operational data and enable predictive analytics, while leveraging digital technologies to support clinical supply chain and patient safety.
GDO also partners with external organizations and leading academic institutions, such as MIT, to spark innovation in AI and Machine Learning focused on better patient outcomes.
At the heart of GDO are our people: we are committed to building a more diverse, equitable and inclusive culture not only within our own walls and our communities, but also across our clinical trials.
It is our passion for people that transforms our work into meaningful action.Come join a team that has earned trust for more than two centuries and advances transformative therapies with honesty, integrity and fairness.
Job IDR
Date posted
02/23/2024
Location
Lexington, Massachusetts
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
Takedas 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 Development Center Americas, Inc.
is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements:
Masters degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience
Prior experience must include:
Develop and maintain study-specific data management documentation such as CRF Specifications, Edit check specifications, Data Management Plan, and Data Cleaning Plan documentation, etc.
; design and develop data capturing tools:Electronic Data Capture (EDC)
Systems (Eg:
iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF)
QC review eg:
Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions).
Up to 20% travel required. Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. Up to 100% remote work allowed from any location in the U.S.Takeda Compensation and Benefits Summary
We understand compensation is
an important factor
as you consider the next step in your career. We are committed to
equitable
pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
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
Takedas 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 Development Center Americas, Inc.
is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements:
Masters degree in Pharmaceutical Sciences, Pharmacology or Toxicology or related field or foreign academic equivalent plus 6 years of related experience
Prior experience must include:
Develop and maintain study-specific data management documentation such as CRF Specifications, Edit check specifications, Data Management Plan, and Data Cleaning Plan documentation, etc.
; design and develop data capturing tools:Electronic Data Capture (EDC)
Systems (Eg:
iMedidata Rave and IBM Clinical) eCOA, IRT; Manage electronic Trial Master File (eTMF)
QC review eg:
Veeva Vault; Lead the Audit and Inspection/Submission Readiness activities like documentation of QC and preparing Storyboards (Eg: FDA/EMA Submissions).
Up to 20% travel required. Company headquarters in Lexington, MA. Individual may reside anywhere in the U.S. Up to 100% remote work allowed from any location in the U.S.Apply on-line at
and search for Req #R
Takeda Compensation and Benefits Summary
We understand compensation is
an important factor
as you consider the next step in your career. We are committed to
equitable
pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Lexington, MA
U
S Base Salary Range:
$133, $209,000.00
The estimated salary range reflects
an anticipated
range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education
attained
, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
The actual base salary offered will be
in accordance with
state or local minimum wage requirements for the job location.
U.S. based
e
mployee
s
may be eligible for
s
hort
t
erm and/
or
l
ong-
t
erm
incentive
s
.
U.S.
based employees
may be
eligible to
participate
in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and
well-being
benefits, among others. U.S.
based employees are also eligible to receive, per calendar year, up to
80 hours
of sick time, and new hires are eligible to
accrue
up to
120 hours of paid vacation.
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.
LocationsLexington, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
As a member of GDO, you will play an important role in bringing forward our rich pipeline of life-changing products to help patients.
You will find enriching engagement and a mindset of continuous improvement through creativity, innovation and diversity.We are a global organization present in the U.S., Europe and Asia with colleagues located in several additional countries to strategically support our business needs.
But our people, and the culture they build, are the foundation that sets GDO apart. Our belief in putting people first extends beyond patients. It includes their families and communities, and also our Takeda colleagues and our families.Working closely with GDO colleagues and key stakeholders across R&D, you will leverage our new operating model and innovative technologies to accelerate the development of our current and future portfolio to bring medicines to patients faster.
Advance clinical researchDeliver clinical analytics and study insights using innovative technologies to improve trial accessibility and patient centricity
Enable end-to-end management of clinical supply
Ensure safety management and inspection readiness
One of the main reasons
I came to Takeda is because of the people I would be working for. We all use PTRB as our North Star.
I think that makes it easier to delegate decisions and empower each level of the organization to contribute in a meaningful way.
Its leveraging technology, its leveraging data in a very different way. Its not just about using the data that we generate, butusing real world data and having access to a much more holistic set of data
in order to drive the way we work and deliver medicines to patients.
Penny Carlson - Head of Innovation and Data, Global Development Office
The culture at Takeda is very unique. Its
a culture thats extremely collaborative
in nature, requiring people from diverse backgrounds to come together, speak up, and really think about the most important thing we need to do for our patients.
Saurabh Awasthi - Executive Director, Trial Insights & Performance Optimization, Global Development OfficeThe heart of our work
Shining a light on new perspectives
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas.
Check out our pipeline and see how well continue delivering a steady stream of next-generation therapies.Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.
Our belief in putting people first extends beyond our patients it includes their families and communities, as well as our Takeda colleagues and their families.
We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.
IntegrityPerseverance
Inclusion
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceTop Workplace
Recognized for our culture and way of working, were one of only 17 companies to receive Top Global Employer status for 2024.
Work-LifeWork-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Empowerment
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to
Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
Patient story:
Rosie
Watch this video to learn about the extraordinary journey that Rosie and her parents have endured.
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