Senior Clinical Study Manager

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🔥 8 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $136k - $171k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Penumbra, Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

Healthcare • Manufacturing • Healthcare Insurance

Penumbra, Inc. is a global healthcare company focused on developing innovative technologies to help patients worldwide. Specializing in the production of medical devices for neuro and vascular conditions, Penumbra offers products such as thrombectomy devices, embolization catheters, and MRI-compatible systems. The company is dedicated to advancing patient care with next-generation software solutions like Lightning Flash 2. 0, designed for the rapid removal of blood clots and treatment of pulmonary embolism. Penumbra is committed to improving outcomes for conditions like stroke, brain aneurysm, and heart attack, supported by clinical evidence and investor growth strategies.

📋 Description

• Develops/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 management. • Manages distribution, collection and tracking of regulatory documentation to help ensure audit readiness at both the sites and Penumbra headquarters. • Negotiates study budgets with sites, Core Labs, and other vendors. • Attends site visits as necessary (e.g., site initiation, monitoring, and close out visits). • Contributes to process improvements that help foster continuous improvement. • Helps update and maintain study trackers and dashboards. • Participates in system user acceptance testing. • Manages vendors such as Core Lab. • Organizes and manages Investigator Meetings. • Works with data management to develop systems for and track project metrics. • Leads activities for internal and regulatory audits. • Monitor progress of studies, identify study-related trends/issues and with the clinical team, implement corrective actions when necessary. • Coordinates activities associated with study start-up and management. • Provides solutions to challenges such as enrollment in the clinical study. • Represents the Clinical Affairs Department on cross-functional meetings and projects as needed. • Works with and communicates effectively with cross functional teams including Regulatory Affairs, Marketing, Legal, Customer Service, R&D, Finance, and Sales. • Attends scientific conferences and interacts with key opinion leaders. • Maintains proactive communication regarding all study related activities with study PIs. • Assists management with regulatory submissions and other clinical study reports. • Supports 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, etc. • Assists team members in managing challenging investigators/staff. • Assists in selection of vendors, such as Core Labs. • Travels as needed to meet project milestones.

🎯 Requirements

• Bachelor's degree in Biological Sciences or related field with 7+ years of experience, or equivalent combination of education and experience • 7+ years of relevant clinical trial experience required (clinical/scientific research, nursing, or medical devices/pharmaceutical industry) • Project management experience including at least 1 clinical project of increasing complexity and at least 1 complex multicenter US/OUS trial. • Field experience preferred • Medical device, pharmaceutical, biotech, or other regulated industry experience desired • Must be familiar with laws, regulations, standards, and guidance governing the conduct of clinical studies including knowledge of CFR and GCP/ICH requirements. • Proficiency with Microsoft Office, MS Project, EDC Systems, study management systems, and vendor oversight. • Ability to solve problems creatively with keen attention to details; ability to work on teams on multiple projects simultaneously. • Working knowledge of medical terminology required. • High degree of accuracy and attention to detail • Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously • Excellent oral, written, and interpersonal communication skills with fluency in English and local language, if different is required.

🏖️ Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded. • A generous benefits package that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).