Job Title: Clinical Operations, Compliance – Process & Training role
Location:Santa Monica, CA
Duration: 06 Months.
Description
Clinical Operations, Compliance – Process & Training role
Key Responsibilities
Drive the development, optimization, alignment and implementation of clinical trial processes across Clinical Development
Partner with equivalent client functions for development, optimization and alignment of shared clinical trial processes
Establish and maintain the training curricula for Clinical Operations and support other Clinical Development functions, as needed
Develop Onboarding plans for Clinical Operations
Support transition planning within Clinical Operations as needed
Proactively monitor compliance with Clinical Operations procedural documents and training requirements
Develop and report process and training compliance metrics
Support and participate in internal audits and regulatory authority inspections, as needed
Support audit/inspection response development and CAPA implementation, as needed
Maintain awareness of changes within the industry and regulatory environment (i.e. ICH E6 (R3)) to ensure Clinical Development processes are updated as necessary
Lead and support efforts to increase compliance awareness and a culture of compliance
Knowledge & Skills
In depth knowledge of international GCP regulatory requirements
Deep understanding of end-to-end clinical trial processes
Organizational Awareness
Independently lead and manage cross-functional initiatives.
Excellent communication skills, provide clear and concise instructions.
Negotiate sensitive issues in an objective manner.
Critical and creative thinking to be able to resolve complex problems.
Ability to prioritize and adjust workload to meet evolving department and regulatory needs.
Lead by example to champion quality and compliance
Seniority level
Director
Employment type
Contract
Job function
Research, Analyst, and Information Technology
Industries
Pharmaceutical Manufacturing
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