The Opportunity:

We are searching for an individual contributor to join our Alameda, California team with comprehensive knowledge in specific areas. We need someone with the ability to execute highly complex or specialized projects. Someone who also adapts precedent and may make significant departures from traditional approaches to develop solutions. This individual will be assisting the manager in the leading & mentoring of the junior clinical staff.

What you will do:

• Plans, directs, creates and communicates clinical study timelines.

• Gathers input from cross-functional teams and creates plans that help the team produce deliverables on schedule.

• Ensure consistency of clinical studies and processes across clinical trials.

• Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations such as the approved release of investigational devices for clinical studies.

• Develop and refine SOPs for existing and new staff and training clinical sites on clinical procedures, when needed.

• Ensures study is conducted within clinical trial protocols.

• Monitors progress and follow up with team members and line managers when issues develop.

• Identify and participate in process improvement initiatives. May participate in a lead role for a project

Qualification Requirements:

• Associate’s degree with a minimum of 5-7 years of industry experience; bachelor's degree preferred.

• Must be able to travel up to 25%-30%.

• Strong communication and written skills.