Posted to MedZilla on 8/17/2019

Takeda Pharmaceuticals

US-MA, Senior Study Operations Specialist R0009728-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 Senior Study Operations Specialist in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Study Operations Specialist working on the Clinical Development Services team, you will be empowered to prepare execute inspection readiness strategy and work with third parties on documentation tasks, and a typical day will include:


The overall purpose of this position is to provide:

  • Inspection Readiness
  • Documentation Management
  • Partnership
  • Operational data support throughout all phases of drug development and in support of the execution of Takeda s global clinical trials


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
  • 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

Operational Information/Data Support/Partnership Support

  • Manage and support tracking of operational data and information through existing dashboard, systems and trackers to support inspection readiness and partnership needs
  • Work with CRO partner and other stakeholders to review, organize and manage operational clinical trial information and operating model repositories
  • Manage operational data analysis and reporting to inform and document trends and risk areas to key stakeholders
  • Establish, maintain, and analyze key performance and operational metrics
  • Support data entry and management of key operational information as needed in various systems
  • Provide end to end centralized end user/customer support for managing and tracking information for specified functional areas within Research & Development (R&D).
  • Provide general support for various forums and meetings including but not limited to meeting planning and organization, generating agenda and minutes, following up on action items



  • 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

Behaviors/ Competencies:

  • 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


  • 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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Cambridge, MA

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Full time

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