Clinical Trials Manager

Highly Competitive Salary
  1. Permanent
  2. CRA Manager, Project/Study Manager (CSM/CPM), Program Manager / Director
  3. United States
Santa Monica, USA
Posting date: 12 Oct 2020

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.