Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Clinical Operations, Compliance - Process & Training
Posted: 10/04/2024
2024-10-04
2024-11-12
Employment Type:
Contract
Job Category: Clinical Development and Operations
Job Number: 614731
Is job remote?: No
Country: United States
Job Description
Target PR Range: 100-120/hr
*Depending on experience
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 Gilead functions for development, optimization and alignment of shared clinical trial processes
· Identify and Lead Process Improvement opportunities
· 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
*Depending on experience
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 Gilead functions for development, optimization and alignment of shared clinical trial processes
· Identify and Lead Process Improvement opportunities
· 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
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