Inspection Readiness & Spon-sor Oversight- Senior Study Ops Specialist
Takeda Pharmaceuticals
Job Description
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Job ID R0021689 Date posted 07/21/2020 Location Boston, Massachusetts
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Job DescriptionJob/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
Boston, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job ID R0021689
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