Manager, Study Start Up

Glaukos Corporation•San Clemente, CA

About The Position

To provide operational leadership for the Glaukos Clinical Affairs Department and supervisory leadership for the Clinical Research Associate (CRA) team to execute Glaukos clinical studies to the highest standards.

Requirements

Bachelor's Degree In biological science, nursing, or other health-related discipline
8+ years of relevant industry experience
At least 1 year of previous people management experience
Ability to work independently, take initiative, and have a flexible approach with respect to work assignments.
Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills.
Ability to demonstrate and foster teamwork within the group as well as at the clinical sites.
Ability to travel, based upon the needs of the department.

Responsibilities

Provide oversight and guidance to operational aspects of the Clinical Affairs Department.
Continually assess, improve and create both internal and external Clinical Affairs departmental processes for efficiency, effectiveness, and usability. To include but not limited to study site payment processes, maintaining visibility of study subject status through the various study stages, management of UBM and imaging services and any internal reading centers.
Support the Study Managers and Clinical Relations management in execution of study conduct in a highly matrixed environment
Working with the Field Training Manager, serve as a resource for process and protocol guidance to foster consistency amongst the team.
Respond to site and CRA inquiries and communicate guidance in a timely, clear, concise and objective manner.
Provide managerial supervision to the CRA team, serving as the direct supervisor for CRA's.
Work in conjunction with the Field Training Manager to assure CRA competencies.
Work in conjunction with the Study Managers, Clinical Relations management and Field Training Manager to assure the CRA team has the most current guidance on site level study administration.
Oversee the CRA hiring process, and assure appropriate CRA staffing levels.
Provide ongoing assessments of CRA work satisfaction to maximize retention and provide a best in class CRA team.
Work closely with Clinical Affairs management to ensure both CRA and site satisfaction; maintain a positive, results oriented work environment both within Glaukos and at the clinical sites.
Participate in SOP and process development as needed.
Prepare necessary reports as required by Glaukos.