Clinical Trial Management Associate

The Clinical Trial Management Associate (CTMA) is a key member of Clinical Operations and will closely partner with the Senior Clinical Trial Manager. Accountable for study level tracking as assigned by the Clinical Project Manager; e.g. monitor visit tracking and sample tracking. Ensures patient enrollment activities are conducted in a timely manner and is comfortable communicating with site personnel. Provides study level information to enable accurate and efficient supply of clinical product to the sites. Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services. Accountable for ensuring that agendas for meetings are clear and distributed in advance; takes comprehensive and precise minutes for internal and external meetings. Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track. May participate in review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies. Provides regular study updates to the appropriate internal stakeholders. Maintains internal Clinical Operations databases and document repositories. Performs administrative duties in a timely manner as assigned. Assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations. Adheres to Clinical Operations processes and SOPs.