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Associate Director Clinical Operations

2 months ago

Santa Monica, United States Net2Source Inc. Full time

Job Description:

Job Description: Associate Director*

Location: Santa Monica, CA 90404

Duration: 06+ Months (Extendable)

Pay Rate: $100 - $128/hr on W2

ID: GILDJP00015700



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


Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.