Posted to MedZilla on 4/19/2018


Takeda Pharmaceuticals

US-MA, Manager, Clinical Research - Oncology Global Medical Affairs R0001136-MZ


 
 

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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, Clinical Research at our Cambridge, Massachusetts office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager, Clinical Research working on the Oncology Global Medical Affairs Research team, you will be empowered to make meaningful contributions, and a typical day will include:

POSITION OBJECTIVES:

  • Oversee and manage the operational planning and execution of phase 4 studies, including development of study protocols, project plans, budgets, and reports
  • Contribute to vendor management, including contract negotiations, scope of work development, and oversight of study-related activities
  • Contribute to the development of phase 4 trial management best practices within the Global Medical Affairs (GMA) oncology organization

POSITION ACCOUNTABILITIES:

  • Manages Clinical Trial Working Group to ensure study goals and objectives are achieved and studies are executed within agreed timelines, budget, and in accordance with internal SOPs and GCP/GPP.
  • Drives the cross-functional review of protocols/amendments, informed consent forms, case report forms, communication plans, training materials, and other trial-related documents, as necessary.
  • Creates and manages study budget(s) by coordinating vendor and site budget negotiations, liaising with procurement/legal when necessary (e.g. Clinical Trial Agreement negotiation); establishing per patient cost assumptions; and anticipating ancillary costs. Develops and maintains tracking tools to ensure that trial costs are accurately predicted, tracked, and reported. Identifies cost savings.
  • Manages or provides oversight to CRO(s) in preparation of study documentation (e.g. study manuals, monitoring plans, communication plans, investigator and patient-facing training materials); in investigator/site identification, feasibility, and start-up; in data management processes, inclusive of data entry and cleaning; in ensuring Trial Master File, maintained by CRO(s), is accurate and current.
  • Monitors clinical trial progress according to study project plans.
  • Consolidate and analyze data for trial progress reports for senior Oncology Business Unit (OBU) leadership.

EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Bachelor s degree required in scientific or healthcare discipline; Master s degree preferred in scientific or healthcare discipline
  • 5+ years in clinical development/research in the biotech/pharmaceutical industry and/or healthcare related field
  • Thorough understanding of FDA, EMEA, ICH, and GCP guidelines, as well as a thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, regulatory affairs, and legal affairs
  • Working knowledge of MS Office software inclusive of Excel, Word, Project or other project management software preferred
  • Ability to work effectively within or lead when appropriate cross-functional teams and in a matrix organization
  • Ability to manage multiple priorities
  • Experience in both interventional and observational studies preferred

TRAVEL REQUIREMENTS:

  • Up to 10%

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.

#LI_DC1

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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