Associate Clinical Trial Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the daily operations of one or more Phase 1–3 clinical trials, encompassing start-up, execution, and close-out tasks.

• Facilitate the tracking of clinical trials under the supervision of Clinical Trial Management.

• Gather, monitor, and perform initial completeness evaluations of site regulatory documents for Investigational Product release and Trial Master File filing.

• Organize, uphold, and engage in audits and the closing of the TMF/eTMF.

• Keep tracking spreadsheets updated for subjects, essential documents, samples, and investigational product progress.

• Oversee and coordinate activities with CROs and third-party vendors, including meeting minutes, study updates, and tracking systems.

• Examine site regulatory documents for precision and adherence to SOPs and regulatory standards.

• Provide prompt updates for ClinicalTrials.gov regarding site modifications and changes.

• Manage the routing of CDAs, contracts, and work orders through the legal approval process.

• Review invoices from sites and vendors, generating monthly/quarterly accruals for finance.

• Support site tools, clinical trial initiation, study materials, pharmacy manuals, vendor setup, and specifications.

• Communicate with sites, CROs, and CRAs/monitors to aid in start-up, study execution, and close-out.

• Monitor trial progress, keeping track of visit reports, unresolved issues, clinical lab samples, shipments, and central reader/lab data.

• Utilize EDC/CTMS systems to gather and analyze clinical trial data, metrics, and reports.

• Aid in organizing internal, investigator, and trial-specific meetings, including minute-taking and action item tracking.

• Travel as required by business needs and perform other designated tasks.

⛳️ Requirements

• Bachelor’s degree (B.A./B.S.) is required.

• A minimum of 5 years of experience supporting clinical trials.

• Fundamental understanding of clinical trial operations, ICH GCP Guidelines, and relevant regulatory requirements.

• Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, SharePoint, and Outlook.

• Capability to prioritize and handle competing demands effectively.

• Ability to collaborate efficiently with study teams, cross-functional team members, and external partners.

• Willingness to travel; the role requires approximately 30% travel.

• Capacity to perform sedentary tasks that involve sitting for most of the time with occasional walking or standing.

🏝️ Benefits

• Comprehensive health insurance options.

• Generous paid time off and holiday schedule.

• Opportunities for professional development and growth.

• Collaborative and inclusive work environment.