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TITLE

 

CLINICAL PROCESS AND COMPLIANCE MANAGER (CONTRACT)

COMPANY

 

Impel NeuroPharma

LOCATION

 

Seattle, WA, US

Description

ACCOUNTABILITY OBJECTIVE:

This position will assist with ongoing GCP compliance activities within Clinical Operations and by Impel’s clinical trial management teams and ensure adherence to applicable CGP regulations and guidance. Assist implementation of electronic systems, e.g. EDMS. Assists with the development, implementation, maintenance and training associated with Clinical Operations SOPs and other work process guidance. Assists with the development of clinical trial quality management plans and processes. Assists with the preparation and support for Regulatory Authority GCP inspections. Collaborates with Impel’s Clinical Quality Assurance group as necessary.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Develops new SOPs and associated documents as well as the monitoring, identification, and addressing any gaps
  • Contributor to the Impel NeuroPharma Clinical Quality Management System
  • Collaborates with Impel Clinical Quality Assurance in the preparation and support of Regulatory Authority GCP inspections
  • Assists Clinical Operations staff with interpretation and application of global GCP regulations
  • Performs Clinical Quality Management compliance assessments/investigations
  • Assists with clinical trial GCP training of Impel staff
  • Assists Clinical Operations in formulating responses to quality observations/findings

EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED

  • 5 years’ minimum experience in the pharmaceutical/biotech industry or relevant clinical research organization experience, including clinical auditing &/or monitoring &/or trial management experience
  • BA/BS required
  • Experience authoring Clinical Operations Department SOPs
  • Proficient in risk management principals and experience with Clinical risk assessments
  • Significant knowledge of global clinical trial regulations and guidelines
  • Experience in supporting clinical trial GCP compliance and clinical quality management activities
  • Experience in supporting Regulatory Authority GCP inspections
  • Experience working in a rapidly growing company while quality and compliance systems are being established (preferred)
  • Previous experience conducting or supporting clinical site and/or vendor audits (preferred), development of CAPAs and monitoring their implementation to successful resolution
  • Excellent interpersonal and communication skills (both written and oral)
  • Ability to problem solve and delegate appropriate tasks
  • Ability to work independently and manage deadlines
  • Strong leadership skills, self-motivated, calm under pressure and adaptable to a dynamic environment
  • Proficiency in MS Word, Excel and PowerPoint

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines

WORKING CONDITIONS

This is a fast-paced environment with moderate noise level. Limited travel may be required.

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