Uncubed
           

Clinical Study Manager

Penumbra, Alameda, CA

Innovative Medical Devices


The Clinical Study Manager is central to the success of Penumbra's clinical trials. You will operate with substantial latitude, overseeing the planning, design, and execution of clinical studies to assess the safety and effectiveness of our products. Interfacing with a variety of internal and external stakeholders, you will ensure the integrity of study tracking data; coordinate and lead investigator meetings; and develop recruitment strategies and project plans.

What You'll Work On

  • Coordinate activities associated with study start-up and management.
  • Develop and maintain project timelines, budgets, and prepare regular operations reports.
  • Develop study-related documents, including Case Report Forms, study protocols, study manuals, and coordinate distribution to to investigational sites and review committees.
  • Manage distribution, collection, and tracking of regulatory documentation to assure audit readiness at the sites and at Penumbra headquarters.
  • Support the study team by resolving protocol-specific questions, such as patient eligibility and protocol deviations.
  • Monitor progress of studies, communicating updates to study team, identifying trends and issues, and implementing corrective actions when necessary.
  • Mentor staff regarding protocols and good clinical practices.

What You Bring

  • A proven knack for managing projects, establishing realistic timelines, meeting deadlines, and achieving objectives.
  • A passion for innovation in health care.
  • Great communication skills -- oral, written, and interpersonal.
  • Bachelor's degree in Biological sciences or a health-related field.
  • High competency with computer applications (Word, Excel, MS Project, study management systems), and enthusiasm for learning new systems.
  • At least 5+ years' experience in clinical research, including experience supporting or managing sponsor and/or investigator-led studies, and knowledge of CFR and GCP/ICH requirements. 
  • At least 3+ years' of managing Device studies on own working with internal stakeholders including Safety, Biostats, and Regulatory.

What We Offer

  • A collaborative teamwork environment where learning and growth are constant.
  • The opportunity to be at the forefront of technology 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 innovative products and has a broad portfolio that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and vascular. Penumbra sells its products to hospitals 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, disability or protected veteran status.

About Penumbra

PENUMBRA TODAY Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on interventional therapies. Penumbra designs, develops, manufactures and markets innovative devices and has a broad portfolio of products that addresses challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals 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.

Penumbra

Want to learn more about Penumbra? Visit Penumbra's website.