To ensure regulatory compliance and quality in clinical studies and trials by conducting systematic and independent audits of trial related activities and documents
Requirements
- Bachelor degree or higher, in Chemistry, Biochemistry, Biology, or equivalent field, or equivalent combination of education and experience, in the pharmaceutical industry
- Knowledge of GCP and GCLP and associated regulatory documents
- Ability to interpret GCP and GCLP and associated regulatory documents to facilitate auditing and process improvement recommendations
Responsibilities
- Audits phases of clinical studies, reports, and performs related duties to ensure regulatory compliance
- Audits all disciplines including Screening, Recruiting, Clinical Operations, Clinical/Safety Laboratory, SRA, Data Services
- Performs in-life audits, process audits, vendor qualifications, equipment and software validation audits
- Writes and issues inspection reports
- Ensures through phase and data inspections that the SOPs are current and practiced
- Identifies and communicates opportunities for process improvement based on audit and inspection observations
Other
- Ability to build and maintain effective working relationships throughout the organization
- Excellent communication and interpersonal skills
- Ability to work in a team environment
- Ability to identify and communicate opportunities for process improvement
- Ability to participate in and guide process improvement activities
