Senior Clinical Trial Manager

Character Biosciences•Jersey City, NJ

1d•Hybrid

About The Position

Character Biosciences is seeking a Senior Clinical Trial Manager to lead all aspects of clinical trial management from study-start up through study closure. This role will independently manage one or more Phase 1-2 studies, or complex components of larger trials, with cross-functional interdependencies and vendor management. The ideal candidate will thrive in a fast-paced startup environment where quick thinking, adaptability, and effective execution of early phase studies are essential to success. This is a preferred hybrid role based at our Jersey City, NJ or Brisbane, CA office, with remote work being a possibility.

Requirements

BA/BS degree with 5+ years pharmaceutical/biotech clinical trial management experience, with at least 2 years in Phase 2.
Specific experience in retina studies within ophthalmology therapeutic area.
Proven ability to lead cross-functional teams and manage sites, and vendors independently.

Nice To Haves

3+ years of retina specific Clinical Trials operations.
Strong knowledge of ICH/GCP guidelines and regulatory requirements.
Expertise in trial planning, protocol development, and study database setup.
Demonstrated ability to manage sample collection, data reconciliation, and complex assessment schedules.

Responsibilities

Plan and manage day-to-day operations of assigned early-stage retina studies.
Develop operational plans with effective cross-functional communication.
Lead design and development of core study documents (protocols, ICFs, study plans, manuals, reports) and systems setup.
Create and maintain detailed study trackers; Track study metrics and proactively escalate issues impacting quality, timelines, or subject safety.
Collaborate with study teams to identify and select high-quality retina specialists and investigative sites.
Setup and execute effective investigator, site monitor and study team trainings.
Manage complex schedules of ophthalmology-specific assessments and coordinate proper execution; candidate should have a comprehensive understanding of retina specific assessments and imaging modalities, including the appropriate order of procedures and coordination of imaging workflows to support data integrity and minimize assessment variability.
Oversee CROs and key vendors (central imaging, central lab, data management, pharmacovigilance).
Help support vendor selection, contract negotiation and performance management.
Manage vendor invoice reconciliation.
Develop study oversight plans and conduct ongoing risk assessment and mitigation.
Serve as primary operational contact for clinical sites and internal stakeholders.
Facilitate site engagement and communications to support study milestones.
Oversee lab database and kit builds, sample management processes, and inventory tracking for retinal specimens.
Manage EDC build, CRF development, and data reconciliation throughout study lifecycle.
Oversee investigational product management including distribution and resupply.
Ensure clinical inspection readiness and compliance with quality standards.
Develop essential project documents including manuals, forms, and monitoring tools.
Participate in clinical operations infrastructure development and process improvement initiatives.