Clinical Trial Manager

Ray 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. Reporting to the Vice President, Head of Clinical Operations, Science & Quality, the Clinical Trial Manager (CTM) is responsible for the management of clinical trials from study start-up activities through close-out ensuring adherence to timelines, budget and regulatory requirements.

The CTM drives completion of study deliverables, ensuring the highest level of data quality and integrity. The CTM provides leadership to clinical research associates, communicates effectively with internal teams, investigators and senior management and has exceptional organizational skills.

• 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

Qualifications:

• 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

Compensation Range and Benefits:

• For this role, the anticipated base salary range: $125,000 to $160,000, based on the candidate's professional experience level. The final salary offered for this position may take into account a number of factors including, but not limited to skills, education, and experience.
• Ray Therapeutics also offers annual performance-based bonus, annual equity awards and a comprehensive benefits package.

At Ray Therapeutics, we celebrate diversity and are committed to creating an inclusive environment for all employees; providing an environment of mutual respect where equal employment opportunities are available to all applicants and teammates without regard to race, color,…