Ray Therapeutics, Inc. · 4 hours ago
Clinical Trial Manager
Berkeley, CA
Full-time
Hybrid
Mid Level
$125K/yr - $160K/yr
4+ years expRay Therapeutics, Inc. is a clinical stage biotechnology company developing best-in-class vision restoration therapies for people with degenerative retinal diseases independent of genetic mutation. The Clinical Trial Manager is responsible for the management of clinical trials ensuring adherence to timelines, budget, and regulatory requirements while providing leadership to clinical research associates and ensuring data quality and integrity.
BiotechnologyHealth CareTherapeutics
Hiring Manager
Sharon Cohen, SPHR, GPHR
Responsibilities
Manages day-to-day clinical operations activities under the oversight of the Clinical Operations senior management including but not limited to clinical site management, study timelines, and metrics; study document development and review (training documentation, ICF, study specific plans, lab and site procedure manuals, etc.), plans and manages study-specific meetings (e.g. Study Team Meetings, Investigator meetings, etc.)
Ensure clinical trials are executed in compliance with the protocol, regulatory and ICH/GCP guidelines including but not limited to participating in the planning of quality assurance activities and coordinating resolution of audit findings; ensuring audit-ready condition of clinical trial documentation; and reviewing monitoring reports to ensure quality and resolution of site-related issues
Execute clinical monitoring, site initiation visits and close out visits in adherence to Good Clinical Practices (GCPs)
Provide direction, training and support to CRAs
Manages the study submissions to IRB/ECs in coordination with CRO, as appropriate
Assist in vendor selection and is responsible for the management/oversight of external vendors
Prepares and presents study status and metrics to the clinical study team
Uses operational and therapeutic expertise to optimize trial execution
Assists in site selection and approval and manages the start-up processes toward activating sites; develops relationships with investigators and site staff
Interfaces with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff)
Oversee TMF management and review TMF documents as necessary
Qualification
Required
Bachelor's degree in life science or health-related field
Minimum of 2 years of clinical trial management and 2+ years clinical research associate with on-site/remote clinical monitoring experience in the biotechnology/pharmaceutical/CRO industry
Robust understanding of ICH/GCP, and knowledge of regulatory requirements
Strong clinical study/project management skills with Phase I experience preferred
Excellent communication, written and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills
Ability to motivate and collaborate with cross functional teams
Ability to work independently and meet company goals within timelines and budget
Able to work in a fast-paced environment with multiple competing tasks and demands
Proficient electronic data capture (EDC) software and other clinical trial technologies such as electronic Trial Master File (eTMF)
Ability to travel up to 20%
Ability to work from our Berkeley, CA office a minimum of 2 days per week
Preferred
Strong clinical study/project management skills with Phase I experience preferred
Benefits
Annual performance-based bonus
Annual equity awards
Comprehensive benefits package
Company
Ray Therapeutics, Inc.
Ray Therapeutics Inc (RayTx) is a late-stage preclinical Bay Area biotechnology company pioneering the first-to-market precision optogenetic therapy for vision restoration that is highly active in ambient lighting (and will not require light-enhancing goggles).
2-10 employees
Funding
Current Stage
Early StageTotal Funding
$122MKey Investors
California Institute for Regenerative MedicineNovo Holdings4BIO Capital
2025-04-24Grant· $8M
2023-11-13Grant· $4M
2023-05-16Series A· $100M
Leadership Team
Paul Bresge
Co-Founder and Chief Executive Officer
Terry O’Neal
Chief Operating Officer
Recent News
2025-04-26
Company data provided by crunchbase