Associate Clinical Trial Manager – Temporary

Role Overview

• Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Management
• Collect, track and conduct initial review for completeness of site regulatory documents and/or TMF filing
• Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)
• Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking
• Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
• Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
• Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations
• Communicate directly with sites handling triages, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with study conduct, and/or close-out activities
• Assist with tracking of clinical trial progress including status update reports, as requested
• Assist with the organization, management and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking
• Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates
• May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues
• Other duties as may be assigned

Requirements

• A./B.S. degree required
• At least 5 years of work experience supporting clinical trials
• Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
• Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, SharePoint and Outlook
• Ability to prioritize and manage competing priorities
• Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• 401(k) matching
• Flexible working hours
• Paid time off
• Professional development opportunities