Associate Clinical Trial Manager

About the Company

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate, 4D-150, is designed to be a backbone therapy for blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection. The lead indication for 4D-150 is wet age-related macular degeneration, currently in Phase 3 development, with a second indication in diabetic macular edema. The Company’s second product candidate, 4D-710, is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.

About the Role

4DMT seeks a motivated and experienced Associate Clinical Trial Manager to support the Company's clinical trial activities. This position will support the day-to-day operations of one or more Phase 1-3 clinical trials, including trial start-up, conduct, and close-out activities. The role requires strong professional written and verbal communication skills, good organization, attention to detail, and the ability to consistently provide high-quality work while managing competing priorities and tight timelines. This person must thrive in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.

Responsibilities

• Coordinate tracking of 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 for 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 with applicable SOPs and regulatory guidelines.
• Ensure timely updates are provided to CTM for updating of ClinicalTrials.gov (site updates/changes).
• Track and route new CDAs, contracts, and Work Orders through the 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.
• Contribute to the creation and maintenance of study materials, including site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications, and presentations.
• Assist in tracking trial investigational product (IP) and development of Pharmacy Manuals.
• Participate in study vendor set-up and specification processes, 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 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 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 (e.g., enrollment data, randomizations, data cleaning, SAEs) for CTM, specific meetings, or management updates.
• May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues.
• Travel as business needs demand (<5% anticipated).
• Perform other duties as assigned.

Requirements

• B.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 (Word, Excel, PowerPoint, SharePoint, and Outlook).
• Ability to prioritize and manage competing priorities.
• Team-oriented with the ability to effectively collaborate with study teams, cross-functional team members, and external partners.

Travel

Up to 30% travel may be required.

Physical Requirements and Working Conditions

• Physical Activity:
  • Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers.
  • Fingering: Picking, pinching, typing, or otherwise working primarily with fingers rather than with the whole hand or arm.
  • Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements:
  • Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
• Working Conditions:
  • The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

Pay

Base salary compensation range: $117,000 - $132,000. The actual salary offered depends on various factors, including geographical location, relevant work experience, skills, and years of experience.