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

Job/Position:

Inspection Readiness & Sponsor Oversight- Senior Study Operations Specialist

Location:

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

Leadership

Ability to communicate and influence stakeholders

Complexity

Internal and external business stakeholders with a mix of business

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• 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

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0021689