Head of Clinical Data Management
Company: Takeda Pharmaceutical
Location: Center Valley
Posted on: May 13, 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
Are you looking for a patient-focused, innovation-driven company
that will inspire you and empower you to shine? Join us as Vice
President, Head of Clinical Data Management.
At Takeda, we are transforming the pharmaceutical industry through
our R&D-driven market leadership and being a values-led
company. To do this, we empower our people to realize their
potential through life-changing work. Certified as a Global Top
Employer, we offer stimulating careers, encourage innovation, and
strive for excellence in everything we do. We foster an inclusive,
collaborative workplace, in which our global teams are united by an
unwavering commitment to deliver - Better Health and a Brighter
Future -to people around the world.
Here, you will be a vital contributor to our inspiring, bold
mission.
Responsible for:
Establish and drive global data management strategy related to
resourcing, technologies and processes to maximize efficiency,
innovation and data quality
Lead and organize the global data management function to provide
data collection, management and integration expertise in support of
global development projects and marketed products including all
therapeutic areas and business units; ensure functional strategy
supports the portfolio priorities
Accountable for meeting annual goals, objectives and deliverables
for both internal and external Clinical Data Management (CDM)
stakeholders
Develops, implements and oversees an operational data ownership
strategy in support of the global portfolio
Liaise with various internal and external groups (GPTs, regions,
Clinical Operations, Statistical and Quantitative Sciences, Global
Patient Safety Evaluation, and external vendors and CROs) for the
implementation of data management activities needed for clinical
studies across all phases of clinical drug development.
Provide insight on latest technologies and changes in regulatory
environments, enabling emerging priorities and efficient data
management leadership for global development programs.
Lead systematic professional development and provide strong support
for direct reports and other members of the Clinical Data
Management function
ACCOUNTABILITIES
Data management and data integrity oversight:
Ensure timely and high-quality data management deliverables
supporting the Takeda portfolio
Responsible for Sponsor Oversight of Data Management deliverables
and activities performed by Strategic Partners, CROs, other 3rd
Party Vendors or FSPs
Responsible for the receipt and management vendor data to ensure
asset and study level strategies are properly - implemented
Lead implementation of clinical data management best practices
(e.g., cross-functional data review, emerging data collection
technologies, etc.)
Data Operations and FSP Management
Accountable for resourcing algorithms,
Serve as Subject Matter Expert and data-specific liaison for
Process, Training and Compliance and other internal
initiatives/projects
Design and implement clinical data management best practices,
ensuring engagement with key stakeholders on critical processes
such as cross-functional data review; issue escalation, etc.
Build and maintain relationship with one or more Functional Service
Providers, designed to provide staff augmentation and support build
of new and/or improved data management capabilities
Metrics, Analytics and Reporting
Lead development of Clinical Data Management metrics, represent CDM
function in projects and initiatives related to the reporting and
analytics capabilities, including but not limited to R&D
Dashboards, Portfolio level performance and productivity and
predictive analytics/reporting
Business ownership of systems and definitions and ongoing support
of clinical data
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS degree in Computer Science, Life Science or other technical
field required; advanced degree desired.
15-20+ years of applicable informatics, systems and /or relevant
drug development experience; global experience and experience in
drug development strongly preferred.
10-15+ years of data management and leadership experience
Knowledge of clinical data management principles, regulations and
best practices, as well as common software products and
technologies used in drug development
Ability to develop and evaluate business cases and effectively
manage budgets
Good knowledge of FDA and ICH regulations and industry standards
applicable to drug development systems
Knowledge of regulations and best practices related to data
collection, electronic records and signatures and data privacy.
Senior leadership experience in Clinical Data Management or related
field, leading a medium to large organization and influencing
executive-level management and key stakeholders
Proven track record of leading and driving business process
transformation and organizational culture change as well as
delivering on programs with complex business deliverables
Operational experience in pharmaceutical drug development with
significant direct exposure to clinical development
Track record of successful leadership, management, and development
of large, multi-disciplinary globally dispersed teams. Strong judge
of talent with the ability to make tough talent decisions.
Health care business acumen with a comprehensive understanding of
the pharmaceutical industry
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution
Plan
Tuition reimbursement Company match of charitable contributions
Health & Wellness programs including onsite flu shots and health
screenings
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs
In accordance with the CO Equal Pay Act, -Colorado Applicants Are
Not Permitted to Apply.
Discover more at - takedajobs.com
No Phone Calls or Recruiters Please.
ADDITIONAL INFORMATION
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.
#LI-CS1
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
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Keywords: Takeda Pharmaceutical, Bethlehem , Head of Clinical Data Management, Healthcare , Center Valley, Pennsylvania
Click
here to apply!
|