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Job Description

OBJECTIVES: 

• Perform day-to-day management of CTMS and eTMF, including oversight of the review and approval of eTMF documents and generation of reports to measure completeness, accuracy, and timeliness of the eTMF, as per applicable regulations and guidelines, and Takeda requirements

ACCOUNTABILITIES: 

• Lead the development of the study specific eTMF plans for assigned clinical studies.
• Perform quality control of documents submitted to the eTMF using the established acceptable criteria
• Ensure clinical trial documentation is consistent with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPs
• Address eTMF questions pertaining to how documents are filed, and user questions related to the eTMF system
• Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as needed
• Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.
• Monitor and identify study-specific eTMF trends and communicate to Clinical Operations and/ or other functional teams as needed
• Assist with inspection/audit related activities (e.g., preparation, correction action plans)
• Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory requirements
• Support Clinical Operations Lead/ Clinical Operations Manager in performing CRO oversight as per agreed parameters
• Collaborate with study team leads to lead the set-up of studies, study teams and sites in the CTMS ensuring programs are configured according to the specific study requirements including: countries and sites; grant access for internal and 3rd party vendor users; baseline expected deviation categories, study/visit plans, visit report & letter templates and baseline milestones
• Manage end-user and group permission settings.
• Lead meetings to escalate trends, issues, and establish standards based on current industry standards, while problem solving and seeking appropriate endorsement across study teams and functions.
• Continually assess that CTMS features are functioning properly and efficiently; track all issues & observations for future enhancement, bug fixes, or ongoing needs for training of CTMS features for continuous improvement of the management of the system.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Minimum Bachelor’s degree in science/healthcare field required
• 3+ years of relevant clinical research and TMF experience at a biotechnology, pharmaceutical company or CRO required
• Previous experience working in eTMF system software; experience in Veeva Vault CTMS & eTMF system software preferred
• Good working knowledge of GCP and local clinical trial rules and regulations
• Organizational and problem-solving skills
• Superior communication, strategic, interpersonal, and negotiating skills
• Proven/ stable performance records over past 2-3 years

TRAVEL REQUIREMENTS:

• Domestic travel may be required (20-30%), including some weekend commitments.
• Limited international travel (10-20%) may be required.

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