Project Manager, Clinical Affairs
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
To assist in the management of clinical projects and studies by collaborating with Clinical Affairs management in the implementation of various team and company objectives for the execution of clinical studies.
* Provide project support for both U.S. and Outside the U.S. Clinical Trials consistent with applicable regulations, guidelines and policies
* Able to tactically execute successful clinical programs and activities
* Ensure conformance with GCP
* Assists by collaborating in the developing, communicating, and building of programs that support division and company objectives
* Investigate and solve problems that impact work processes and personnel in multiple departments
* Skillfully develops, nurtures and maintains relationships with investigators, coordinators, site staff and all members of ZOLL with whom this individual works
* Assist with adhering to study execution strategy in order to meet business objectives
* Assists in the creation and implementation of immediate and long-range plans to carry out objectives for new and ongoing clinical trial research in support of regulatory submissions in a timely and efficient manner
* Able to simultaneously balance multiple business, clinical, product and physician requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* Must have relevant experience executing clinical programs in cardiovascular medical devices, particularly interventional cardiology or ICU-based clinical trials.
* BS degree in life sciences plus 5 years of related work experience, or equivalent combination of education and experience
* Prior people management and clinical trial project management experience required
San Jose, California, United States