Job description
This position will report into the senior director, clinical operations - clinical complianceIn this role you will be a key member of the kite align team and work cross-functionally with the clinical development organization at kiteKite align drives process and training alignment across the kite clinical development organization and with gileadYou will also partner closely with research & development quality & compliance and equivalent functions at gilead.
Key responsibilities:
Drive the development, optimization, alignment and implementation of clinical trial processes across kite clinical development
Partner with equivalent gilead functions for development, optimization and alignment of shared clinical trial processes
Identify and lead process improvement opportunities at kite
Provide kite clinical operations sme support to the gilead progress and pom teams
Establish and maintain the training curricula for clinical operations (inclusive of clinical operations, data management and clinical logistics) 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
Maintain awareness of changes within the industry and regulatory environment (i.eIch e6 (r3)) to ensure clinical development processes are updated as necessary
Lead and support efforts to increase compliance awareness and a culture of compliance
Basic qualifications:
Bachelor’s degree in science or related fields, and 7+ years of experience in a gcp environment - or –
Master’s degree in science or related fields, and 5+ years of experience in a gcp environment
Preferred qualifications:
Knowledge & skills:
In depth knowledge of international gcp regulatory requirements
Deep understanding of end-to-end clinical trial processes
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
Note: this position can be based in santa monica, ca or be remote-based.
