General Summary
The Associate 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. Qualified applicants must be eligible to work for any employer in the U.S. without sponsorship, and must currently reside in the continental United States.
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.
- 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.
Position Qualifications
Minimum education and experience:
- Bachelor's degree in Biological Sciences or related field with 2+ years of experience, or equivalent combination of education and experience.
Additional qualifications:
- 2+ years’ relevant clinical trial experience (i.e., clinical/scientific research, nursing, or medical devices/pharmaceutical) industry required.
- 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 desired.
- 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.
Working Conditions
- General office environment.
- Willingness and ability to work on site. May have business travel from 5% - 15%.
- Potential exposure to blood-borne pathogens.
- Requires some lifting and moving of up to 10 pounds.
- Must be able to move between buildings and floors.
- Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
- Must be able to read, prepare emails, and produce documents and spreadsheets.
- Must be able to move within the office and access file cabinets or supplies, as needed.
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 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).
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.
