Posted to MedZilla on 10/13/2019

Takeda Pharmaceuticals

US-MA, Inspection Readiness & Sponsor Oversight- Senior Study Operations Specialist R0009381-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 anInspection Readiness & Sponsor Oversight- Senior Study Operations Specialist in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Inspection Readiness & Sponsor Oversight- Senior Study Operations Specialist working on the Global Development Operations team, you will be empowered to provide inspection readiness and sponsor oversight support, and a typical day will include:


  • Documentation Management
  • Risk Assessment, ICH E6 R2 compliance support


Inspection Readiness- Overall

  • Manage oversight of inspection readiness activities by working with CRO partners and ensuring work is completed in a manner consistent with Takeda s expectations and inspection readiness framework
  • Conduct risk assessments to ensure compliance with regulations and guidances (e.g., ICH E6 R2 compliance support)
  • Define, implement and manage solutions to inspection readiness issues in collaboration with CRO partners and cross functional Takeda stakeholders
  • Proactively identify issues and resolutions associated with inspection readiness activities, escalate as needed
  • Work with functions to share Takeda s/GDO s inspection readiness framework and expectations and project manage efforts, escalate as needed
  • Utilize Veeva reports and other reports to measure and manage functional area documentation and it relates to inspection readiness

Inspection Readiness- Documentation/TMF

  • Lead documentation teams at Takeda and CRO partner to execute inspection readiness strategy
  • Work with CRO partners to proactively manage trial documentation and understand mapping of key documents utilizing Takeda s inspection readiness framework
  • Work across R&D and GDO to support focus on study documentation throughout the trial lifecycle
  • Assist with SOP listing documentation needed in TMF for each study
  • Assist with story boards for studies in conjunction with Clinical Operations
  • Serve as key point of contact for documentation within Clinical Operations and facilitate documentation standards across R&D
  • Track and manage key actions and agreements when working with CRO partners and key stakeholders in support of documentation efforts

Documentation Management

  • Manage incoming documentation from CRO Partners to ensure that appropriate filing, scanning and/or archiving occurs, as appropriate
  • Work with third parties to manage, ensure processing of documentation and/or delivery of information/documentation, as needed
  • Facilitates retrieval and preparation of study documentation from multiple sources to support inspection and or audit requests


  • Strong organizational skills and techniques
  • Strong adaptive communication skills across multiple levels of the organization
  • Strong attention to details
  • Tolerance of ambiguity and willingness to work through complex issues
  • Ability to work with global external partners to achieve desired goals
  • Ability to develop solutions to complex issues and challenges
  • Promotes team work while working through solutions
  • Proficiency with MS Office Applications, Sharepoint, Visio, etc.


Technical/Functional (Line) Expertise

Knowledge and experience with clinical trial processes and TMF, including TMF systems


Ability to communicate and influence stakeholders

Decision-making and Autonomy

Ability to think through solutions and options and offer recommendations for endorsement


Internal and external stakeholder interactions are required


Ability to share knowledge and develop innovation solutions to issues


Internal and external business stakeholders with a mix of business


  • Bachelor s degree
  • Minimum of 2-4 yrs of experience in pharmaceutical, CRO, healthcare or related industry.
  • Knowledge and/or experience within clinical trial operations and clinical trial lifecycle.
  • Willingness to learn and work in multiple TMF systems, shared workspaces, etc


  • 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

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No Phone Calls or Recruiters Please.



Cambridge, MA

Worker Type


Worker Sub-Type


Time Type

Full time

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