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Manager/ Senior Manager Clinical Data Solutions

Boston, Massachusetts

Overview

Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines. The Greater Boston Area is headquarters to many of our Global and US business units.

We are a passionate team doing important work that impacts patients’ lives. If you are driven to create better health and a brighter future, join us!

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Team Player
  • Versatile
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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Manager/ Senior Manager Clinical Data Solutions

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Job ID R0011166 Date posted 08/08/2019 Location Boston, Massachusetts

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career?  If so, be empowered to take charge of your future at Takeda.  Join us as a Manager/Senior Manager, Clinical Data Solutions in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager/Senior Manager, Clinical Data Solutions working on the  team a typical day will include: 

OBJECTIVES: 

  • Responsible for timely and high quality data management deliverables supporting the Takeda portfolio.
  • Establish asset and study level strategies and services, including excellence in the application of standards.
  • Responsible for data management oversight of the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget
  • Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.  Activities include from protocol synopsis through database release and submission
  • Contributes to the management of vendor partnerships to maximize effectiveness and maintain budgets.
  •  Provides and enables solutions for complex problem solving that align with the Takeda values.
  • Serves as a clinical data management expert and provides guidance on CDISC standards.

ACCOUNTABILITIES: 

  • Responsible for vendor oversight activities across global development programs. 
  • Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions.
  • Contributes influential leadership in collaboration with other Takeda Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
  • Provides input to functional governance with Takeda’s strategic suppliers.  Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
  • Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
  • Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
  • Oversees the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. 
  • Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of Takeda.
  • Participates and represents function in formal inspections and audits as requested.
  • Other duties as assigned

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  

Education:

  • BS/BA required preferably in a health-related, life science area’

Experience:

  • Minimum of 8years data management and/or drug development experience.
  • Proven track record of strong project management skills and experience managing data management activities for large drug development programs
  • Experience with all phases of development and at least 2 therapeutic areas.
  • Ability to handle multiple development programs simultaneously.
  • NDA/CTD Experience.
  • Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
  • Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance.
  • Good understanding of CDISC standards, and experience implementing standards.
  • Strong knowledge of clinical study reporting requirements including SAS programming.
  • Advanced knowledge of office software (Microsoft Office).
  • Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles.
  • Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools.
  • Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.
  • Able to influence without authority
  • Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
  • Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo
  • Pragmatic and willing to drive and support change
  • Is comfortable with ambiguity
  • Embody a culture of continual improvement and innovation; promote knowledge sharing

Travel:

  • Requires approximately 5-20 % travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel.

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

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0011166

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