Associate Clinical Study Manager

Summary

Join Penumbra as an Associate Clinical Study Manager and lead the planning, design, and execution of clinical studies. You will work with confidential data, collaborating with internal and external stakeholders. This role requires managing project timelines, study documents, regulatory documentation, and budgets. Essential functions include negotiating with vendors, attending site visits, and ensuring compliance with quality management systems. The position demands strong communication, problem-solving, and organizational skills, along with experience in clinical trials and relevant regulations.

Requirements

• Bachelor's degree in Biological Sciences or related field with 2+ years of experience, or equivalent combination of education and experience
• 2+ years’ relevant clinical trial experience (clinical/scientific research, nursing, or medical devices/pharmaceutical) industry
• Familiarity 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; fluency in English 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
• High degree of accuracy and attention to detail
• Excellent organizational skills with the ability to prioritize assignments while handling various projects simultaneously
• Eligibility to work for any employer in the U.S. without sponsorship
• Current residency in the continental United States

Responsibilities

• Develop and maintain project timelines from startup to completion, including database build, data snapshots, reports, abstracts, manuscripts, DSMB, CEC meetings, and regulatory submissions
• Drive the development, approval, and distribution of study-related documents and tools for investigational sites and review committees
• Manage the distribution, collection, and tracking of regulatory documentation to ensure audit readiness
• Negotiate study budgets with sites, Core Labs, and other vendors
• Attend site visits (initiation, monitoring, and close-out)
• Contribute to process improvements
• Update and maintain study trackers and dashboards
• Participate in system user acceptance testing
• Manage vendors such as Core Lab
• Organize and manage Investigator Meetings
• Work with data management to develop systems for and track project metrics
• Adhere to the Company’s Quality Management System (QMS) and relevant regulations
• Understand and adhere to relevant security, privacy, and compliance principles and regulations
• Ensure other department members follow the QMS, regulations, standards, and procedures
• Perform other work-related duties as assigned

Preferred Qualifications

Project Management experience

Benefits

• Medical, dental, vision insurance
• Life, AD&D, short and long-term disability insurance
• 401(k) with employer match
• Employee stock purchase plan
• Paid parental leave
• Eleven paid company holidays per year
• Minimum of fifteen days of accrued vacation per year, increasing with tenure
• Paid sick time in compliance with applicable law(s)
• Collaborative teamwork environment
• Opportunity to be part of a team revolutionizing disease treatment