Associate Clinical Trial Manager

Summary

Join 4DMT, a clinical-stage biotherapeutics company, as an Associate Clinical Trial Manager to support clinical trial activities. You will be responsible for the day-to-day operations of phase 1-3 clinical trials, including trial start-up, conduct, and close-out. Strong communication, organization, and attention to detail are crucial for success in this fast-paced environment. The role requires managing competing priorities and tight timelines while collaborating effectively with a team. You will contribute to various aspects of clinical trial management, from regulatory document review to data tracking and analysis. This position offers opportunities to work on multiple projects and contribute to the advancement of innovative genetic medicines.

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
• Travel: 30%

Responsibilities

• 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 for IP release 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, and sample and investigational product tracking
• Track and coordinate CRO and third-party vendor activities, including vendor provided meeting minutes, study updates and trackers
• Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines
• Ensure timely updates are provided to CTM for updating of ‘Clinicaltrial.gov’ (site updates/changes)
• Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders)
• Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
• Assist with the development of site tools and clinical trial start-up activities
• 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
• Assist in tracking of trial IP and development of Pharmacy Manuals
• Participate in study vendor set up and specification process, as appropriate
• Communicate directly with sites, Contract Research Organizations (CROs) and CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, 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
• Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation
• 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
• Willing to travel as business needs demand ( < 5% anticipated)
• Other duties as may be assigned

Benefits

Base salary compensation range: $120,000/yr – $166,000.00/yr