Director, Clinical Affairs 8/11/2016
San Jose, CA
JOB DESCRIPTIONAPPLY ZOLL San Jose is a division of ZOLL Medical Corporation, an Asahi Kasei Group company. ZOLL Medical develops and markets medical devices and software solutions that help advance emergency care and save lives while increasing clinical and operational efficiencies. ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. The San Jose Division includes products for therapeutic temperature management, circulation, and CPR feedback.
ZOLL has an open position for a Clinical Affairs Director in its San Jose Division. The position assists in the management of clinical affairs activities and trials for our medical device products in locations throughout Europe and the United States. Responsibilities include the ability to manage parallel clinical trials in accordance with Good Clinical Practices, PMDA, FDA or other regulations. The position assists in the management of clinical affairs consultants, external service providers and trial sites.
* Provide overall management for clinical trials as assigned
* Manage all aspects of trial budgets, costs, and site payments
* Originate clinical trial protocols and ancillary documents
* Provide project/study management and monitoring plans for projects
* Develop and maintain relationships with investigators, coordinators and site staff
* Ensure conformance with GCP, ISO, MDD, CFR and other regulations as necessary
* Investigate and solve problems that impact work processes and personnel in multiple departments
* Ability to develop presentation materials and make presentations to senior staff
* Assist with the planning, preparation and presentations at Investigator Meetings
* Ability to multitask business, clinical, product and physician requirements
* BS degree in life sciences plus 10 years of related work experience, MD or PhD preferred
* Experience developing and executing clinical programs for medical devices, including prior clinical trial project management
* Prefer MD orPhD. Minimum requirement: BS degree in life sciences plus 10 years of related work experience, or equivalent combination of education and experience
* Prior people management and clinical trial project management experience required
* Fluent in both written and spoken English
Experience leading trials under ISO 14155:2011.
San Jose, California, United States