[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.

Responsibilities

• 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
• Monitor 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
• 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
• 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
• Perform other work-related duties as assigned

Skills

• 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
• Field experience preferred

Benefits

• A benefits and equity program, when applicable
• 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
• Paid sick time in compliance with applicable law(s)

Company Overview

Company H1B Sponsorship