Senior Clinical Trial Manager (Contract)

The role

This person will oversee and manage the day-to-day operations of a Phase 3 multi site clinical study. Responsibilities include managing protocol execution, vendor management, and CRO oversight.

What you will do

• Manage protocol execution and oversight of the CRO, study service providers, and consultants
• Support establishment of study milestones and tracking of study metrics and timelines
• Ensure clinical trials are executed in accordance with ICH GCP, regulations, protocol, and company SOPs
• Assist in the preparation and review of clinical trial documentation
• Develop internal tracking and reporting tools
• Support the management of the Trial Master File to ensure compliance and inspection readiness
• Participate in and coordinate the resolution of audit findings
• Identify, mitigate, and manage risks
• Support the selection and study-specific training of CRO staff, monitors, and investigational sites
• Facilitate study start-up with CROs and clinical sites

Required qualifications

• B.A./B.S. degree
• 7+ years of clinical research experience within the biotech industry or a similar combination of experience
• Experience with vendor management and CRO oversight
• Experience developing trial plans including site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management
• Knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial management
• Understanding of the regulatory framework applicable to interactions with HCPs, payers, advocacy groups, and other business partners
• Proven leadership skills to direct protocol execution
• Excellent communication skills
• Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology
• Excellent organizational, conflict resolution, prioritization, and negotiation skills
• Proficient computer skills with Microsoft Office Suite
• Working knowledge of MS Project

Nice to have

• Some ophthalmology experience

Before you apply

• No unsolicited resumes from agencies will be accepted

About the company

4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics. The company's lead product candidate 4D-150 is designed for the treatment of blinding retinal vascular diseases.