Clinical Trial Manager (San Diego, CA)

Summary:
The Clinical Trial Manager (CTM) is responsible for managing and supporting clinical trials in compliance with applicable regulations, ICH/GCP guidelines, and standard operating procedures (SOPs). The CTM works collaboratively with cross-functional teams and partners with internal and external stakeholders to align activities with study goals and timelines.

Responsibilities:

• Manage daily operations of clinical trials to ensure timely and compliant completion.
• Oversee tracking systems for study details, training, and trial metrics.
• Contribute to the development and review of study materials, such as case report forms (CRFs) and informed consent documents (ICFs).
• Support site feasibility, start-up, and activation processes, including document collection, ICF review, and site platform access setup.
• Conduct or participate in pre-study visits (PSVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs).
• Review monitoring visit reports for quality and completeness.
• Serve as the point of contact for site communications, providing updates and resolving inquiries.
• Attend study team meetings, preparing and distributing agendas and minutes.
• Set up, maintain, and perform quality reviews and final reconciliation of trial master file (TMF) documents.
• Assist with budget management, including review, tracking, and collaboration with clinical finance teams.
• Perform remote query resolution and data reviews to support clinical data management (CDM).
• Carry out additional duties as assigned.

Requirements:

• Bachelor’s degree required, preferably in life sciences or a related field.
• At least 5 years of clinical research experience, including previous CTM experience.
• Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements.
• Experience managing global Phase 3 trials is highly preferred.
• Background in CNS indications, particularly Alzheimer’s disease, is a plus.
• Strong organizational, communication (written and oral), and technical skills.
• Proficiency in Microsoft Office Suite, CTMS, EDC, QMS, and other relevant systems.
• Ability to prioritize tasks, delegate effectively, and problem-solve with sound judgment.
• Willingness to travel domestically and internationally, up to 15% of the time.

Department: Direct Clients
This is a full time position