Senior Manager, Clinical Data Management - Lexington, United States - Takeda

Description

Senior Manager, Clinical Data Management

At 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.

We're 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 ID

R

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

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 Development Center Americas, Inc.

is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements:
Master's 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

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 Development Center Americas, Inc.

is seeking a Senior Manager, Clinical Data Management in Lexington, MA with the following requirements:
Master's 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.

Locations

Lexington, 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 research
Deliver 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.

It's leveraging technology, it's leveraging data in a very different way. It's not just about using the data that we generate, but

using 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. It's

a culture that's 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 Office
The 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 we'll 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.

Integrity
Perseverance
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 Workplace
Top Workplace

Recognized for our culture and way of working, we're one of only 17 companies to receive Top Global Employer status for 2024.

Work-Life
Work-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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