LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.
Job Title: Clinical Operations, Compliance - Process & Training role Location: Santa Monica, CA 90404 Duration: 6 Months Contract Pay Rate: $90/hr - $120 /hr 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 at Kite 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
To know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/
Should you have any questions, feel free to call me on (415) 322-5419or send an email on ******
Thanks and Regards Akarsh Yathiraj Senior Recruiter C. (415) 322-5419 D. (415) 322-5419 A. 611 Gateway Blvd, Ste 120
South San Francisco, CA 94080 W. www.leadstackinc.com
