Ayala Pharmaceuticals is currently seeking candidate for Clinical Trial Manager.The successful candidate must have excellent interpersonal, collaboration and communication skills in a global team environment as well as in small biotech company, with pharmaceuticals companies as well as diagnostics companies.The Clinical Trial Manager is accountable for the day-to-day operations of assigned clinical trials, including start-up, conduct and close-out activities. This position will perform required job duties with guidance to ensure trial timelines and quality metrics are met and the trial is conducted in compliance with the study protocol, SOPs, and applicable regulatory requirements.

 

Key Responsibilities:

  • Serve as the primary contact for managing protocol execution, including oversight of the CRO, service providers, and consultants that are involved in a clinical trial
  • Lead cross-functional study team in support of study deliverables
  • Ensure accurate tracking and reporting of study metrics and timelines
  • Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
  • Participate and respond to Quality Assurance and regulatory authority inspection audits
  • Perform and manage data review process on an ongoing basis
  • Perform site visits including oversight, site qualification, initiation, monitoring and close-out visits, as needed

 

Requirements:

  • Bachelor’s, or equivalent, degree in a scientific discipline
  • 10 years of clinical research experience, with at least 2 years’ experience in planning and managing clinical trials
  • Experienced in Oncology trials
  • Understanding of pharmaceutical regulatory requirements, both US and abroad
  • Self-motivated, assertive and able to function independently or as part of a team
  • Highly effective communication and organizational skills
  • Able to travel 25%-30%
  • Willingness to work from home