Clinical Trials Manager

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

Job Responsibilities:

• Collaborate with Kite Clinical Development to confirm adherence to GCP compliance execution through all stages of clinical trial conduct including but not limited to: core study execution documents, clinical trial sponsor oversight, deviation management and internal audit support.
• Lead the audit response process within Clinical Operations and follow audit response/CAPA commitments to completion.
• Co-lead Global Inspection Readiness activities
• Partner with clinical study teams on risk management/mitigation activities
• Provide Kite Clinical Operations support with noncompliance reporting
• Develop and report compliance metrics
• Support and participate in internal audits and regulatory authority inspections as needed
• Support 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 Operations is aligned.
• Lead and support efforts to increase compliance awareness and a culture of compliance

Skills and Requirements:

• In depth knowledge of international GCP regulatory requirements
• Experience with risk management in clinical trials
• 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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