Kivo is in a growth mode and is searching for an experienced candidate for the position of Clinical Trial Document Specialist, who will be responsible for working directly with customers during the deployment of Kivo Clinical Solutions to support adoption.

ROLE AND RESPONSIBILITIES

Conduct quality checks of eTMF documents.
Reviews the classification and meta data based on the TMF Reference Model filing structure.
Performs record quality checks of documents upload to the eTMF based on client business standards.
Communicates trends and issues to the management.
Participates in reconciliation and/or remediation work.
Ensures all work activities are performed in compliance with requirements of Good Clinical Practice
Performs other activities as assigned to support TMF migrations.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

Minimum of 2 years experience processing documents for Trial Master File
Good working knowledge of the TMF Reference Model filing structure.
Good knowledge of clinical trial documents filed within the Trial Master File
Understanding of ICH/GCP and other regulations pertaining to TMF management for clinical trials and regulatory submissions
Strong attention to detail
Ability to apply business process rules to work activities.
Experience working with eClinical systems.
Ability to work in a fast-paced environment and meet deadlines.
Good communication skills (written and verbal)
Strong organizational skills and ability to complete tasks to deadlines independently.
Strong proficiency in MS Office Suite