Responsible for the management and oversight of phase I-IV clinical trials, with a key focus on Phase 1-2a, from start up through CSR including, but not limited to, development of project documentation, training project staff, monitoring study progress, assessing protocol adherence, administration and oversight of study budgets, monitoring oversight of site-level activities related to ongoing and planned trials, management of third-party vendors for clinical services, management of project timelines and deliverables.
Provide scientific expertise throughout the lifecycle of a drug product including the development and implementation of clinical protocols. Review, evaluate and present study data, contribute to clinical study reports, investigator brochures, regulatory documents, and publications. Work collaboratively across functions to ensure the integrity of Neumora-sponsored clinical trials.
Lead and manage CTIMP and non-CTIMP clinical trial programs, ensuring successful delivery. Act as the primary contact between Lindus Health and the Sponsor. Be accountable for project partner activities and proactively manage issues. Maintain project information, timelines, and inspection readiness. Manage a small team and collaborate with tech and product teams to design trial technology.
The Senior Manager Patient Recruitment role serves as the critical link between patients, advocacy groups, and internal clinical teams to ensure that the patient voice is integrated throughout the clinical trial lifecycle. You will be building and maintaining relationships with global and regional patient advocacy groups and individual patient representatives. You will act as the primary point of contact for patient organizations related to clinical trial education and collaboration.
This position serves as an expert in Study Start Up (SSU) activities and strategy including the use of various clinical systems (e.g. CTMS) to enable consistent and compliant forecasting and data collection. Manage and may lead the day-to-day operations within Study Start Up to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.