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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

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