Clinical Operations Manager job in Santa Monica, USA

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: CRA Manager, Program Manager / Director

Location: United States

This vacancy has now expired

Proclinical is currently recruiting for a Clinical Operations Manager with a pharmaceutical company located in Santa Monica, CA.

Job Responsibilities:

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.

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