[Remote] Associate Director of Clinical Operations

Note: The job is a remote job and is open to candidates in USA. Neurona Therapeutics is seeking an Associate Director of Clinical Operations to oversee the successful execution of clinical trials from protocol concept through completion. The role involves managing various clinical aspects of studies, ensuring compliance with regulations, and leading cross-functional teams to optimize trial design and execution.ResponsibilitiesManage all clinical aspects of studies including, but not limited to:Assess operational feasibility and prepare study execution plansDevelop and manage comprehensive study timelines and metricsOversee vendors:Participate in selection and management/oversight of external vendorsDevelop vendor specificationsCreate, maintain, and implement vendor oversight plans for critical vendors (e.g., CROs)Review vendor reports, budgets, and metricsGenerate and/or review study-specific training materials for sponsor study team, CRO, CRAs, sites, and other personnelPrepare and present project debriefings as requiredPlan, execute, and lead study-specific meetings (e.g., Clinical Study Team Meetings, Investigator Meetings, DSMBs, Advisory Committees)Use operational expertise to optimize trial design and execution by providing input on protocol, informed consent forms (ICF), case report forms (CRFs), monitoring conventions, and edit checksCultivate strong relationships with investigators and site staffManage study budgets within financial goals; review and approve clinical invoices ensuring adherence to scope of work and contractual agreementsEnsure clinical trials comply with international GCP guidelines, regulations, and SOPs:Participate in planning quality assurance activities and coordinate resolution of audit findingsMaintain audit-ready clinical trial documentation including central clinical filesReview monitoring reports and delegated monitoring visit summaries to ensure quality and resolve site-related issuesCoordinate and assist in regulatory or ethics committee activities as appropriateCoach and provide guidance to clinical staff; may have line management responsibilities for clinical trial management personnelLead cross-functional Clinical Study Teams by regularly interacting with Medical Monitors/Directors and internal/external stakeholders including Regulatory Affairs, Data Management, investigators, CROs, and vendorsMaintain up-to-date knowledge of GCP, ICH guidelines, and regulatory requirements for clinical trial managementReview site study documents such as informed consent templates, study tools/worksheets, investigator contracts, and site paymentsParticipate in evaluation, selection, and training of sites and study personnel (contract and internal) to ensure efficient operationsPrepare and/or review and approve study-related documents and templates including Monitoring Plans, Laboratory Manuals, Participant Seizure Diaries, clinical site procedures manuals, Pharmacy Manuals, and CRF Completion GuidelinesSkillsBachelor's degree or equivalent combination of education and experience in a science or health-related field requiredMinimum of 8 years clinical trial experience in pharmaceutical, biotech, or CRO settings, including at least 5 years in trial managementStrong understanding of GCPs, ICH guidelines, regulatory requirements, and experience partnering with Clinical Quality AssuranceStrong clinical study and project management backgroundExcellent written and oral communication and organizational skills, including presentation development, study dashboard maintenance, and early escalation of issuesAbility to learn complex therapeutic areas and protocol detailsResourceful with independent problem-solving skillsComfortable working in ambiguous and dynamic environmentsDemonstrated leadership and team-building experiencePreferred experience includes at least 4 years in a pharmaceutical or biotech sponsor company supporting complex clinical trials and leading cross-functional teamsRegulatory inspection experience is preferredCompany OverviewNeurona Therapeutics is a biotherapeutics company that focuses on developing cell-based therapies to address neurological disorders. It was founded in 2008, and is headquartered in South San Francisco, California, USA, with a workforce of 51-200 employees. Its website is http://www.neuronatherapeutics.com.