Manager, Records Management – LATAM
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Job Description
Manager of Clinical Systems responsible for building Records Management team in LATAM. Overseeing TMF processes and ensuring compliance in clinical trials documentation.
Responsibilities:
- Oversee staff performing TMF-related activities which may include document quality review and processing, TMF quality review, and/or study-level engagement to ensure filing of essential clinical study documents
- Perform review of the study TMF Plan and TMF Document Index to ensure alignment of staff activities with study-specific requirements
- Assist with addressing any cross-functional questions related to TMF management and alignment with study-specific documentation
- Ensure proper execution of role-specific activities and oversee the quality of TMF support provided by Documents Specialists, Quality Review Specialists and/or TMF Leads
- Complete periodic and random quality and completeness checks of work performed by team members.
Requirements:
- Bachelor’s degree (or its international equivalent)
- A minimum of 8 years of related experience, including a minimum of 2 years in a leadership capacity Or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job
- Professional working proficiency in English.
Benefits:
- Professional working proficiency in English
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