Study Manager, Toxicology
$129,000–$160,000 year
Remote
RemoteFull Time$129,000–$160,000 yearSmall
Full TimeSmall
Job Summary
Conduct operational activities for non-GLP and GLP toxicology studies from research through late clinical development phases. Serve as the primary operational contact and representative to contract research organizations, ensuring scientific and corporate objectives are achieved while maintaining compliance with regulations and standard operating procedures. Manage day-to-day study activities, coordinate between internal toxicologists, project management, and CROs, and assist in protocol design, report reviews, and data analysis. Participate in regulatory submissions and facilitate vendor selection and audit processes.
Required Qualifications
- BS degree in science
- minimum 5+ years of relevant experience in biotech, pharmaceutical and/or CRO industries
- Knowledge of current GLP regulations
- Knowledge of ICH guidelines for drug development
- Knowledge of FDA guidelines for drug development
- Ability to travel to CRO partners as needed
Desired Qualifications
- Experience working with Contract Research Organizations (CROs)
- Experience working with internal subject matter experts
- Experience working with toxicologists
- Ability to help design protocols that achieve scientific objectives
- Ability to monitor non-GLP and GLP toxicology studies
- Ability to manage day-to-day study-related activities
- Ability to ensure study objectives are met against project goals
- Ability to ensure compliance with appropriate regulations, policies, standard operating procedures, and international regulatory guidelines/regulations
- Ability to resolve study-related issues
- Ability to liaise with internal experts and/or consultants
- Ability to inform appropriate personnel
- Ability to review protocols
- Ability to review study reports
- Ability to review protocol/report amendments
- Ability to coordinate study-related activities between RevMed personnel and CROs
- Ability to assist with data analysis
- Ability to generate results tables and graphs
- Ability to participate in regulatory submissions
- Ability to prepare applicable nonclinical sections of IBs, NDAs, BLAs
- Ability to review applicable nonclinical sections of IBs, NDAs, BLAs
- Ability to develop and maintain relationships with study directors
- Ability to develop and maintain relationships with principal investigators
- Ability to develop and maintain relationships with external collaborators
- Ability to work with QA to facilitate CRO vendor selection/audit
- Ability to facilitate CRO vendor due diligence activities
- Ability to negotiate contracts
- Ability to manage internal approvals
- Ability to manage execution process
- Ability to support the development of SOPs, policies, and guidelines
- Strong interpersonal skills
- Ability to work with cross-functional project teams
- Ability to work with CROs
- Effective communication, both verbally and in writing
- Ability to facilitate open cross-functional collaboration
- Ability to prioritize responsibilities
- Ability to meet deadlines
- Self-motivated work ethics
- Independent work ethics
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