Associate Clinical Study Manager
Alameda, CA /
General Administration – R&D Clinical /
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. We are currently open to candidates located anywhere in the continental US, provided they meet the qualifications below.
Specific Duties and 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.
Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *
Understands relevant security, privacy and compliance principles and adheres 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.
*Indicates an essential function of the role
Minimum education and experience:
Bachelor’s degree or equivalent experience in a related field, with 2+ years of relevant clinical trial experience (clinical/scientific research, nursing, or medical devices/pharmaceutical industry), or an equivalent combination of education and experience
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
Project Management experience
Excellent oral, written, and interpersonal communication skills, fluency in English & local language, if different, 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
What We Offer:
• 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 that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan
Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.
If you reside in the State of California, please also refer to Penumbra’s Privacy Notice for California Residents.
For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP-Policy-Statement.