Inspection Readiness & Spon-sor Oversight- Senior Study Ops Specialist

Takeda Pharmaceuticals

Job Description

Inspection Readiness & Spon-sor Oversight- Senior Study Ops Specialist
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Job ID R0021689 Date posted 07/21/2020 Location Boston, Massachusetts

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Job Description


Inspection Readiness & Sponsor Oversight- Senior Study Operations Specialist


Cambridge, MA

The overall purpose of this position is to provide:

  • Inspection Readiness and Sponsor Oversight support
  • Documentation Management
  • Risk Assessment, ICH E6 R2 compliance support

Inspection Readiness-

  • 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 life cycle
  • 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


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 life cycle.
  • Willingness to learn and work in multiple TMF systems, shared work spaces, etc

Boston, MA

Worker Type


Worker Sub-Type


Time Type

Full time

Job ID R0021689

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