Manager, Clinical Operations

Manager Of Clinical OperationsWe are seeking a Manager of our Clinical Operations team, to provide leadership in the oversight, management, planning, coordination, and execution of clinical projects. This is a highly hands-on role for someone who wants to impact company development through effective and efficient management of clinical operations staff and activities.This role is ideal for someone who has experience in global Class III active implantable medical device studies, who can manage teams and vendors efficiently and effectively, and who wants to help bring a unique product to market for an underserved patient population.What You'll DoManage a high performing clinical operations team by providing direction, subject matter expertise, training and mentorship.Responsible for managing the design, development, modification, and evaluation of clinical execution plans (e.g., protocol, case report forms, consent forms, source document worksheets, budget, timelines, gap analysis, etc.)Accountable for the comprehensive clinical trial activities including but not limited to study start-up, site activation, site management, vendor oversight, study reports, site and study close-out.Provide technical direction to clinical research organizations (CROs) and oversee vendor selection/management as needed to execute clinical studies.Work closely with hospitals and investigators participating in clinical studies and maintain close working relationships with KOLs, other investigating physicians and site coordinatorsProvide input and support for post-clinical activities and market launch of products.Establish / support cross-functional teams to ensure optimal alignment of Clinical, Regulatory, commercial goals, site operations, data monitoring and review, and safety surveillance and reporting expectations.Ensure clinical research programs are conducted in accordance with company standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulations.What We're Looking ForBachelor's degree in a scientific fieldMinimum 8+ years of relevant clinical research experience in the medical device field, or an advanced degree with a minimum of 5 years of relevant experience in the medical device fieldProven success building and managing clinical operations teamsComprehensive knowledge of clinical operations including Good Clinical Practices and all applicable US regulationsExperience with global clinical studies (e.g., EU or APAC regions)At least 2 years monitoring experienceExperience with Class III medical device clinical studiesEffective verbal and written communication skillsOrganized, self-motivated, ability to effectively manage multiple projects and priorities; high attention to detailMust be a strong team player and effectively interface with other departments including translational medicine, regulatory, quality, product developmentPreferred QualificationsClinical research certification (e.g., CCRP, CCRA, etc)Experience with site and sponsor FDA BIMO inspectionsSuperior problem-solving skills.Experience with urology clinical studiesEffective interpersonal/communication skillsWhat Makes This Role UniqueInnovation – first of its kind device that will require a unique clinical study design.Build & Lead – you'll bring clinical operations expertise to the department and have the opportunity to influence department strategy and implementationImpact – clinical studies are a critical part of product development. Your work here will directly influence time to market and providing a new therapy to an underserved patient population.iota offers a very competitive benefits package that includes the following:Health & WellnessComprehensive health coverage for you and your family, covered at 100%Access to quality dental and vision coverageOnsite Gym in AlamedaWork-Life BalanceGenerous vacation payPaid parental leaveOptions for flexible work schedulesCompetitive CompensationAnnual Bonus PlanLong Term Incentive Plan (LTIP)401(k) plan with employer match