Clinical Study Manager

January 25

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $123k - $170k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

Apply Now

Receive Emails with Similar Jobs

Penumbra, Inc.

WebsiteLinkedInAll Job Openings

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.

1001 - 5000 employees

Founded 2004

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

•The Clinical Study Manager provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. •This position works with confidential subject and company data, and interfaces with a variety of internal and external stakeholders. •Understands business environment and relates extensive knowledge of internal and external activities to trends. •Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units. •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. •Drives development, approval, and distribution of study-related documents including Case Report Forms, study manuals. •Leads activities for internal and regulatory audits. •Monitors progress of studies, identify study-related trends/issues and with the clinical team, implements 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. •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. •Leads moderately complex multidisciplinary (stats, DM, clinical) US and OUS clinical projects. •Evaluates, analyzes, and interprets data and presents in a clear, well organized, scientifically sound report. •Drafts Investigator Meeting content. •Forecasts study timelines and budgets. •Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. •Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. •Ensure other members of the department follow the QMS, regulations, standards, and procedures.

🎯 Requirements

•Bachelor's degree in Biological Sciences or related field with 5+ years of experience, or equivalent combination of education and experience •5+ 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 requirements. •Proficiency with Microsoft Office, MS Project, EDC Systems, study management systems, and vendor oversight. •Excellent oral, written, and interpersonal communication skills with fluency in English and local language, if different is required. •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

🏖️ Benefits

•A collaborative teamwork environment where learning is constant, and performance is rewarded. •The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases. •A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, 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).