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