[Remote] Clinical Study Manager

Note: The job is a remote job and is open to candidates in USA. Penumbra, Inc. is a global healthcare company focused on innovative therapies, and they are seeking a Clinical Study Manager to lead the planning, design, and execution of clinical studies. This role involves managing study-related documents, coordinating with various stakeholders, and ensuring compliance with regulatory requirements.ResponsibilitiesDevelops/maintains project timeline inclusive of startup through completion (e.g., database build, data snapshots for study reports, abstracts, manuscripts, DSMB, CEC meetings, and regulatory submissions)Drives development, approval, and distribution of study-related documents and study tools for investigational sites and review committees as directed by managementManages distribution, collection and tracking of regulatory documentation to help ensure audit readiness at both the sites and Penumbra headquartersNegotiates study budgets with sites, Core Labs, and other vendorsAttends site visits as necessary (e.g., site initiation, monitoring, and close out visits)Contributes to process improvements that help foster continuous improvementHelps update and maintain study trackers and dashboardsParticipates in system user acceptance testingManages vendors such as Core LabOrganizes and manages Investigator MeetingsWorks with data management to develop systems for and track project metricsDrives development, approval, and distribution of study-related documents including Case Report Forms, study manualsLeads activities for internal and regulatory auditsMonitor progress of studies, identify study-related trends/issues and with the clinical team, implements corrective actions when necessaryCoordinates activities associated with study start-up and management. Provides solutions to challenges such as enrollment in the clinical studyRepresents the Clinical Affairs Department on cross-functional meetings and projects as neededWorks with and communicates effectively with cross functional teams including Regulatory Affairs, Marketing, Legal, Customer Service, R&D, Finance, and SalesAttends scientific conferences and interacts with key opinion leaders. Maintains proactive communication regarding all study related activities with study PIsAssists management with regulatory submissions and other clinical study reportsSupports the study team by answering protocol-specific questions (assist in resolution of patient eligibility questions and protocol deviations)Mentors and trains staff regarding protocols, good clinical practice, departmental processes, etcAssists team members in managing challenging investigators/staffAssists in selection of vendors, such as Core LabsTravels as needed to meet project milestonesLeads moderately complex multidisciplinary (stats, DM, clinical) US and OUS clinical projectsEvaluates, analyzes, and interprets data and presents in a clear, well organized, scientifically sound reportDrafts Investigator Meeting contentForecasts study timelines and budgetsAdhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and proceduresUnderstand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the CompanyEnsure other members of the department follow the QMS, regulations, standards, and proceduresPerform other work-related duties as assignedSkillsBachelor's degree in Biological Sciences or related field with 5+ years of experience, or equivalent combination of education and experience5+ years of relevant clinical trial experience required (clinical/scientific research, nursing, or medical devices/pharmaceutical industry)Must be familiar with laws, regulations, standards, and guidance governing the conduct of clinical studies including knowledge of CFR and GCP/ICH requirementsProficiency with Microsoft Office, MS Project, EDC Systems, study management systems, and vendor oversightExcellent oral, written, and interpersonal communication skills with fluency in English and local language, if different is requiredAbility to solve problems creatively with keen attention to details; ability to work on teams on multiple projects simultaneouslyWorking knowledge of medical terminology requiredHigh degree of accuracy and attention to detailExcellent organizational skills with ability to prioritize assignments while handling various projects simultaneouslyField experience preferredBenefitsA benefits and equity program, when applicableMedical, dental, vision, life, AD&D, short and long-term disability insurance401(k) with employer matchPaid parental leaveEleven paid company holidays per yearA minimum of fifteen days of accrued vacation per year, which increases with tenurePaid sick time in compliance with applicable law(s)Company OverviewPenumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. It was founded in 2004, and is headquartered in Alameda, California, USA, with a workforce of 1001-5000 employees. Its website is http://penumbrainc.com.Company H1B SponsorshipPenumbra, Inc. has a track record of offering H1B sponsorships, with 12 in 2026, 36 in 2025, 40 in 2024, 45 in 2023, 43 in 2022, 36 in 2021, 26 in 2020. Please note that this does not guarantee sponsorship for this specific role.