Senior Manager/Manager, Clinical Trial GCP Compliance – MASS
Eagle Research Incorporated - Massachusetts

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Position Summary:
The Senior Manager will play a pivotal role in the development of the Clinical Trial Quality and Compliance function within the Clinical Operations department. The Senior Manager will assist with the development, implementation and maintenance of a proactive GCP compliance management system, including the development of processes and standards, training, and ensuring that regulatory requirements (ICH, FDA, EMA, etc.) and guidelines are adhered to. This individual will also be involved in developing a GCP inspection readiness program and will serve as a GCP compliance expert to the CDMA organization.

Key Responsibilities:
  • Assist with development, implementation and maintenance of a robust GCP quality management system, including development of policies and procedures related to clinical research conduct
  • Lead the development of internal process improvements related to GCP compliance, including implementation of an effective and compliant GCP CAPA management process
  • Develop and deliver GCP and other relevant training to clinical research staff
  • Work with relevant internal functions to develop a GCP inspection readiness program; Liaise with R&D Quality Assurance to support audit and inspection activities; Assist with inspection activities (preparation, conduct, and responses) for GCP inspections at company and investigator sites
  • Serve as subject matter expert concerning GCP and provide compliance guidance to internal clinical research personnel; May mentor and manage junior staff, contractors, and consultants
  • Proactively monitor and assess compliance risks within and across studies; collaborate to address identified compliance risks and promote a state of inspection readiness
  • Perform quality control reviews of key clinical documents; Conduct ongoing quality control assessments of departmental activities and processes to ensure they remain relevant and current
Qualifications Overview:
  • Bachelors degree required; Master’s degree preferred
  • Experience in Clinical Compliance, Clinical Research Monitoring, Clinical Trial Management, and/or , Clinical Quality Assurance within the pharmaceutical/biotech industry ; Proactive approach to GCP compliance
  • Extensive knowledge of FDA / global clinical trial regulations and ICH GCP Guidelines; Understanding of the clinical development process and documentation requirements
  • Knowledge of outsourced models of clinical research conduct and associated sponsor requirements
  • Knowledge of site and vendor auditing processes and recent FDA and EMA inspection findings
  • Ability to work independently with minimal direction
  • Desired: Experience building GCP quality systems, including development of SOPs, effective CAPA programs, and development/delivery of GCP-related training, Experience managing direct reports and contractors/consultants

Eagle Research Incorporated - 19 months ago - save job - block