Sandra Sam Sather

About Sandra Sam Sather

To promote the highest Clinical Quality systems and program development for Sponsors…

Experience

1. Clinical Research Gcp Quality Consultant, Vice-president

   Clinical Pathways, Llc

   Jan 2002 — Present

   A leader in the clinical research industry in promoting clinical quality systems for sponsors, CROs, technology vendors, and investigation sites, SAM has over 30 years of clinical experience with a MS with a specialization in performance Improvement. She is a subject matter expert in many GCP areas, monitoring, auditing, risk management, vendor oversight, HIPAA, inspection readiness and regulations/guidelines. She authors and presents courses for clinical research pharmaceutical and medical device GCP stakeholders for various functional areas. SAM has led the quality management consulting services for CP with a focus on supporting the synthesis of changing regulations into the client\'s clinical quality systems while supporting a culture of change- Management/leadership global experience- CP staff hiring, development and oversight, multiple contractual roles in leadership for clients- Clinical research services on a contractual basis (Quality Management, Training & Development, Monitoring, Auditing, Process Improvement, Program & Change Facilitation)- Quality management system adaption to promote continuous improvement- Assist with and/or develop new or revise existing policies, procedures, quality manuals, training programs to meet current industry regulations and industry initiatives, i.e. integration of quality risk management in GCP systems- Performance Improvement Consultant: analysis of proposed and current organization programs/departments. Conduct performance gap and cause analysis, leading to identifying interventions, implementation and evaluations- Design, develop, conduct clinical research and soft skills training; audience experience size range experience 1-1500. In-person, online, and eLearning- Competency based curriculum development and coordination - Client Types: CROs, sponsors, research sites, technology vendors, training organizations, universities.

Skills

• Regulatory Submissions
• Clinical Development
• Cra Management
• Performance Improvement
• Ctms
• Clinical Data Management
• CRO
• Training & Development
• Training
• Edc
• Sop
• Project Management
• Research
• Pharmaceutical Industry
• Therapeutic Areas
• Clinical Monitoring
• Regulatory Affairs
• Research Project Management
• Gcp
• Employee Training
• Clinical Research
• Clinical Trials
• Oncology
• Ich-Gcp
• Quality Assurance
• Clinical Quality Systems
• Clinical Site Monitoring