Clinical Trial Manager

Role Summary

We are seeking a proactive and experienced Clinical Trial Manager to join our Clinical Operations team, with a focus on early-phase clinical development. In this role, you will serve as the primary liaison between MBX and clinical trial sites, fostering collaborative relationships to ensure high-quality trial execution and accelerate early-phase program success. You will support clinical sites through startup, enrollment, data integrity, and compliance processes, identify and remove operational barriers, and manage our early phase programs.

Responsibilities

• Serves as the primary point of contact for assigned study sites, CROs, and vendors, communicating project updates, addressing inquiries, and resolving issues in alignment with the CTM escalation pathway.
• Leads or contributes to the development and review of regulatory documentation to support study start-up activities, ensuring site readiness and availability of necessary supplies for site initiation visits (SIVs).
• Prepares and presents materials for Investigator Meetings and site-specific training, ensuring consistent messaging and study understanding across stakeholders.
• Executes all clinical trial activities in full compliance with internal SOPs, FDA regulations, and ICH-GCP guidelines.
• Independently supports operational execution across multiple clinical studies, prioritizing subject safety and the integrity and accuracy of clinical data.
• Collaborate with the Clinical Research Associates to maintain essential regulatory documents and study supplies throughout the lifecycle of assigned trials.
• Conducts and/or oversees all phases of site monitoring‚Äîincluding pre-study visits (PSVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs)‚Äîeither independently or in coordination with CRO partners.
• Maintains and monitors study tracking tools to ensure up-to-date status reporting of clinical trial documents and proactively follows up to retrieve outstanding materials.
• Provides leadership and oversight to direct and indirect reports, including recruitment, training, performance management, coaching, and professional development following company policies.
• Performs additional responsibilities and cross-functional support as required to ensure the success of clinical programs.

Education & Qualifications

• Bachelor's degree with 8+ years of clinical experience.
• 7+ years of direct experience with clinical site management, CRO/Vendor management, and logistical execution of clinical trials.
• Experience working in a small biotech or pharmaceutical company is preferred.
• Prior team management experience (direct or indirect).
• Experience with Smartsheet and TMF systems.
• Strong understanding of clinical trials, drug development, Phase I through Phase III.
• Excellent organizational skills and strong attention to detail, with the ability to manage multiple tasks efficiently and effectively.