Clinical Operations Manager
Proclinical is currently recruiting for a Clinical Operations Manager with a pharmaceutical company located in Santa Monica, CA.
- Drive the development, optimization, alignment and implementation of clinical trial processes across Clinical Development.
- Partner with equivalent functions for development, optimization and alignment of shared clinical trial processes.
- Identify and Lead Process Improvement opportunities
- Provide Clinical Operations SME support to the 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.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.
- Manage and grow the Process Improvement & Knowledge Management team as needed
Skills and Requirements:
- 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
If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.