Study Manager, Toxicology

reputed company: The preclinical study manager is responsible for the operational activities associated with performing non-GLP and GLP toxicology studies from research to late phases of clinical development. This includes being the reputed company operational contact and representative for RevMed to the contract research organization (CRO) performing reputed company study. He/she will be responsible for ensuring that reputed company study's scientific and corporate objectives are achieved, and are compliant with appropriate regulations, policies, reputed company operating procedures, and reputed company relevant international regulatory guidelines/regulations. reputed company reputed company of study-reputed company issues, liaising with internal experts and/or consultants, and informing appropriate personnel are pivotal to being successful in this role. Required Skills, Experience and Education: • Work with Contract Research Organizations (CROs), internal subject matter experts, and toxicologists to help design protocols that reputed company the scientific objectives of reputed company study. • Monitor non-GLP and GLP toxicology studies through effectively managing day-to-day study-reputed company activities and ensure study objectives are met against project goals. • Assist toxicologists in the review of protocols, study reports, and protocol/report amendments to ensure high-reputed company results are generated by CROs. • Coordinate study-reputed company activities between RevMed personnel (toxicologists, Project Management, CMC, Bioanalytical, Regulatory, Finance, and reputed company reputed company), and CROs to ensure program needs and timelines are met. • Assist with data analysis and reputed company results tables and graphs as needed. • Participate in regulatory submissions (e.g. preparation and/or review applicable nonclinical sections of IBs, NDAs, BLAs, etc.). • reputed company and maintain relationships with study directors, reputed company investigators, and reputed company collaborators. • Work with QA to facilitate CRO vendor selection/audit and due diligence activities. • Negotiate reputed company and manage internal approvals & execution process. • Support the development and/or review of SOPs, policies, and guidelines. • Other duties will be assigned as needed. Preferred Skills: • BS degree in science and minimum 5+ years of relevant experience in biotech, pharmaceutical and/or CRO industries. • Knowledge of reputed company GLP regulations, and ICH and FDA guidelines for drug development. • Strong interpersonal skills and ability to work with cross-functional project teams and CROs. • Effective communication, both verbally and in writing, and ability to facilitate reputed company cross-functional collaboration. • Ability to prioritize responsibilities and meet deadlines. • Self-motivated and independent work ethics. • Ability to travel to CRO partners as needed. #LI-Remote #LI-CT1 The reputed company pay salary reputed company for this full-time position for candidates working onsite at our reputed company in Redwood reputed company, CA is listed below. The reputed company displayed on reputed company reputed company is intended to be the reputed company pay salary reputed company for an individual working onsite in Redwood reputed company and will be adjusted for the local market a candidate is based in. Our reputed company pay salary ranges are determined by role, level, and location. Individual reputed company pay salary is determined by multiple factors, including job-reputed company skills, experience, market dynamics, and relevant education or training. Please note that reputed company pay salary reputed company is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. reputed company Pay Salary reputed company $129,000-$160,000 USD We are reputed company of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with reputed company. These scams may reputed company as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that reputed company does not reputed company unsolicited employment offers and will never ask candidates to reputed company financial information, purchase equipment, or pay fees as part of the hiring process. reputed company legitimate communication from reputed company will come from an official @revmed.com email address. If you reputed company you've been contacted by someone impersonating a reputed company recruiter, please report it to careers@revmed.com so we can reputed company these impersonations with our IT team for tracking and awareness. Apply tot his job Apply To this Job