Careers

 

Position: Clinical Trials Manager/Director

Status: Regular, Full-Time, Exempt Position, Located in Redwood City, CA

Job Summary: We currently have an opportunity for a Clinical Trials Manager/Director based in the Redwood City, California office who will manage multiple U. S. clinical trials; assist with regulatory submissions and strategies, and manage KIKA Medical Electronic Data Management system for data collection.

Description:

  • Manage US clinical trials for the company
  • Manage KIKA Medical Electronic Data Management system for data collection
  • Monitor activities at clinical study sites to assure adherence to GCP, SOPs and study protocols
  • Participates in corrective and preventive actions (CAPA)-related activities
  • Perform data verification, validation and audits through on-site and in-house monitoring
  • Conduct study initiation and closeout visits
  • Train, mentor and supervise work of CRAs
  • Train and advise clinical study coordinators on the collection of clinical data and good documentation practices
  • Establish and maintain good working relationships with investigators and research institutions involved in clinical trials
  • Assist in the development of CIPs, protocols, CRFs, SOPs and IRB submissions for clinical trials in accordance with Company strategy, sound investigative practices and regulatory requirements
  • Review regulatory documents as required and prepares site visit reports
  • Represent the Company at corporate and medical meetings
  • Assist in preparation of FDA submissions
  • Participate in clinical initiatives and projects as assigned

Position Qualifications:

  • • Requires a BS Degree (RN or other healthcare professional degree highly desirable) or equivalent experience
  • • A quick learner who is independently motivated with no need for micro-management
  • CCRA preferred but not required
  • Five or more years of experience in managing clinical trials and electronic database systems
  • Extensive experience preparing CIPs, CRFs, ICFs, SOPs, and IRB submissions
  • Extensive experience in monitoring clinical trials
  • Extensive knowledge of clinical research requirements and cross-functional understanding of clinical research methodology
  • Expert knowledge of GCP and ICH guidelines and regulations
  • Excellent writing skills and ability to prepare clinical and regulatory reports
  • Ability and willingness for frequent travel
  • Effective written and verbal communication skills
  • Well organized, enthusiastic and detail oriented
  • Proficient computer skills
  • Ability to complete tasks independently in an accurate and timely manner

Equipment to be used in Performance of Job:

  • Computer/laptops/printer
  • Telephone/Blackberry
  • Fax Machine
  • General office equipment

E-mail résumés to hr@endogastricsolutions.com or send to:

HR Manager
EndoGastric Solutions, Inc.
8210 154th Avenue NE
Redmond, WA 98052