Clinical Project Manager (Job ID 1025)
Ray Therapeutics mission is to restore vision to people with retinal degeneration. Ray Tx is using a novel bioengineered optogenetic protein optimized for human vision delivered by AAV to restore visual function in a mutation agnostic approach and without the need for light enhancing eyewear. The company is developing its lead candidate RTx-015 in retinitis pigmentosa, a degenerative retinal disease with significant unmet medical need as well as a pipeline to treat both rare and large market indications.Reporting to the Director, Program Management, the Clinical Project Manager will be embedded with the clinical development team to ensure projects continue to move forward and all timelines are met or exceeded. In this role, you will use your knowledge of the clinical development process to communicate and develop solid relationships with the clinical team members. Your exceptional organizational skills and strategic mindset enable you to anticipate challenges, coordinate activities and keep multiple workstreams on track. You will play a vital role in transforming plans into progress, ensuring that clinical initiatives are executed efficiently, effectively, and with impact.Key ResponsibilitiesPartner closely with the clinical team to ensure the trial is completed on time, within budget, and in accordance with safety standardsWorking with clinical team leaders, map out the full lifecycle of complex clinical development projects from planning through close-outEnsure clinical development is in compliance with FDA regulations, ICH/GCP, and Ray Therapeutics SOPsTrack all study activities, including study planning, site selection and qualification, trial start-up, enrollment, monitoring, data cleaning, and study close-outDevelop and maintain detailed clinical study timelines, highlight any timeline risks and ensure development of risk mitigation strategiesDevelop communication tools for constant clinical team alignment and keeping the PMO informed with progress reports of clinical study activitiesServe as the primary operational point of contact for assigned CROs, vendors, and study partners as applicableSupport vendor selection, contract execution, and ongoing performance oversightOrganize and maintain essential trial documentation, including study plans, monitoring plans, timelines, and operational toolsPartner cross-functionally with Clinical Operations, Regulatory, Medical Affairs, Data Management, CMC, and Quality to ensure aligned trial executionContribute to continuous improvement of clinical operations processes and systemsQualificationsBachelor’s degree in life sciences or a related clinical field5+ years’ experience within clinical research, biotechnology, pharmaceutical, or medical device industries; with 3 years in clinical developmentDemonstrated experience in project management and ability to manage multiple projects simultaneouslyExperience using project management software (Microsoft Project and OnePager)Solid understanding of FDA regulations, ICH guidelines, and GCPExcellent written and verbal communication skills, with proven ability to collaborate across functions and organizationsExperience in Ophthalmology, retina, neurology or gene or cell-based therapies preferredCAPM or PMP Certification preferredAbility to work from our Berkeley, CA office 3 days per week.Compensation Range And BenefitsFor this role, the anticipated base salary is $135,000 - $147,000 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, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. All employment is decided on the basis of qualifications, merit, and business need.Search Firm Representatives Please Read CarefullyRay Therapeutics does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Please, no phone calls or emails.