Careers

Clinical Project Manager at Element Science
San Francisco, CA, US
Summary of Role
We are seeking a Clinical Project Manager to join our growing medical technology company. This individual will be responsible for driving the execution of global clinical trials with cross-functional team participation in support of our business objectives for product development and/or regulatory approvals. The ideal candidate will have excellent people skills and a can-do attitude as well as a passion for working on a cutting-edge, life-saving product.

Deliverables:
Execution of the clinical trial to the Clinical Plan, including managing the schedule, resources, budget and deliverables
Assist in the creation and review of study-related planning documents: Data Management Plans, Clinical Monitoring Plans, Statistical Analysis Plans, Clinical Schedule; oversee their execution to plan.
Participate in the clinical site selection process, Site Qualification and Site Initiation Visits.
Monitor / co-monitor as needed
Develop and maintain positive relationships both internal and external to project, including site personnel.
Identify and manage risks that could derail the project, including risks related to device, subject population/recruitment.
Provide support to team members and promote teamwork
Participate in and/or complete other activities as assigned
Qualifications:
Bachelor’s degree in nursing, life science, biomedical engineering, or related field preferred
Minimum 7 years’ experience in clinical research the medical device industry, including experience with implantable medical devices
Familiarity with European Medical Device Directive, FDA IDE and PMA regulations
Thorough understanding of ISO 14155
Demonstrated project management skills
Strong writing skills
Familiar with software databases: Electronic Data Capture systems, MS Office
Experience in cardiology preferred

Interested? Send a short introduction and your resume.