Country Study Specialist in South San Francisco, CA at Apex Life Sciences

Date Posted: 10/12/2018

Job Snapshot

Job Description


Purpose:

The Country Study Specialist (CSS) is responsible for providing project co-ordination and operational solutions to support Country Study Managers (CSMs) and to provide clinical trial oversight to local study teams to enable effective, high quality trial management.

Responsibilities:

Project Management:

  • Provides insight, experience and lessons learnt to to study start-up and patient recruitment strategies and activities to ensure robust and optimal trial delivery
  • Leads the identification and incorporation of best management, documentation and compliance practices into the conducted of studies run
  • Leads the development and distribution of affiliate newsletters and study updates
  • Manages and ensures that shared study areas are compliant with global and local standards, practices and SOPs
  • Responsible for the oversight and effective coordination of study-related supplies
  • Accountable for ensuring appropriate tracking systems and tools are in place and compliant to regulations, internal policies and ICH-GxP
  • Responsible for the implementation, execution, coordination and oversight of local affiliate audit / inspection activities to address CAPA plans
  • Provides insights and input into project management and monitoring plans
  • Coordinates the country communication plan, and also the budget and payment plan in accordance with the country financial plan
  • Maintains and tracks progress to ensure an up-to-date and efficient country level resource plan
  • Manages, monitors and reviews for quality the Trial Master File (TMF)

Qualifications

  • BA/BS degree¬†preferably in a medical/science-related field
  • Prior work experience demonstrating knowledge and understanding of clinical trials
  • Previous experience managing projects is desirable.

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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