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Clinical Quality Manager

Pasadena, CA | Full Time
9 Days Ago

Job Description

The Position

The Clinical Quality Manager supports the Director of Clinical Quality Management & Training (DCQMT) with eTMF management, eTMF reviews, CRA Assessments, staff training, and quality and compliance management across Clinical Operations activities.

Responsibilities:

  • Support DCQMT in eTMF management
  • Lead CQMT quarterly eTMF reviews for study teams across programs
  • Assist in the preparation and conduct of CRA Assessments
  • Participate where needed in the review of unblinded trip review and provide unblinded support to study teams across programs
  • Assist the DCQMT in the preparation and/or presentation of training documents/sessions/programs for Clinical Operations staff
  • Assist DCQMT in the preparation and/or review of Clinical Operations documents (forms, templates, SOPs/WIs) or other internal documents
  • Participate in the review of SOPs and WIs during annual reviews
  • Assist DCQMT with new hire onboarding and training scheduling
  • Assist DCQMT in the maintenance and review of training metrices
  • Assist the DCQMT in maintaining the Vendor Issues Tracker
  • Support Clinical Quality Assurance (CQA) in health authority inspection preparation activities
  • Assist DCQMT and CQA with document preparation for any internal gap assessments or audits
  • Assist the DCQMT in any additional quality initiatives

Requirements:

  • Experience with eTMF systems and TMF reference model
  • Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
  • Proficient in MS Office (Word, Excel, and PowerPoint)
  • Ability to work in a team or independently
  • Effective interpersonal, written, and verbal communication skills
  • Able to critically evaluate job tasks and the impact on overall study execution
  • Strong problem-solving capabilities
  • Able to effectively collaborate with study team members and other stakeholders
  • Exceptional organizational skills with the ability to multi-task and prioritize
  • Attention to detail
  • Ability to work with distributed team members and outside vendors

Physical or Other Requirements:

  • Standing, sitting, walking, climbing stairs, light lifting, computer operation
  • Occasional travel in the US or overseas (<20%)

Qualifications:

  • Thorough understanding of all applicable FDA ICH- GCP regulations and guidelines
  • At least 7 years of experience in Clinical Operations or similar function
  • At least 2 years of onsite monitoring/site management experience
  • Prefer at least 2 years of experience working in Veeva Vault eTMF/Quality systems set-up and maintenance

Educational Requirements:

  • 4-year college degree (preferred) otherwise, candidates with a combination of education and relevant experience will be considered

 

Company Overview

  • Website arrowheadpharma.com
  • Headquarters Pasadena, CA
  • Size 200 - 500
  • Founded 1989
  • Type
  • CEO CHRISTOPHER ANZALONE
  • Revenue $50M - $200M
  • Industry Biotechnology
  • About arrowhead pharmaceuticals
  • Arrowhead Pharmaceuticals, Inc. develops medicines for the treatment of intractable diseases in the United States. The company's pipeline include ARO-AAT, a RNA interference (RNAi) therapeutic candidate for the treatment of liver diseases associated with alpha-1 antitrypsin deficiency; ARO-APOC3 to treat hypertriglyceridemia; ARO-ANG3 to reduce production of angiopoietin-like protein 3; ARO-ENaC to reduce production of the epithelial sodium channel alpha subunit in the airways of the lung; and ARO-HIF2 for the treatment of clear cell renal cell carcinoma. It is also involved in the development ... of ARO-HBV, a third-generation subcutaneously administered RNAi therapeutic candidate to treat chronic hepatitis B virus infection; AMG 890 to reduce production of apolipoprotein A; and ARO-AMG1 for treating undisclosed genetically-validated cardiovascular target. Arrowhead Pharmaceuticals, Inc. has collaboration and license agreement with Amgen, Inc.; and Janssen Pharmaceuticals, Inc. to develop RNAi therapeutics. The company was formerly known as Arrowhead Research Corporation and changed its name to Arrowhead Pharmaceuticals, Inc. in April 2016. Arrowhead Pharmaceuticals, Inc. was incorporated in 1989 and is headquartered in Pasadena, California. More