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Director/Associate Director, GCP Compliance

Cambridge, MA

Posted: 08/12/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2403

Reporting to the Vice President of Clinical Development Operations, the Director/Associate Director, Clinical Compliance will lead the Clinical Compliance function and will work closely with the Clinical Teams and Quality Assurance to manage and support a culture of quality, regulatory compliance, and continuous Good Clinical Practice (GCP) inspection readiness.

This position is responsible for leading the development, implementation and maintenance of a proactive GCP compliance quality management system, including the development of processes and standards, training, risk assessment, and ensuring adherence to regulatory requirements (ICH, FDA, and EMA) and guidelines. He or she will work to establish a consistent, standardized approach to compliance and collaborate with cross-functional study teams to implement quality by design infrastructure. This individual will be instrumental in developing a GCP inspection readiness program and will serve as a GCP compliance expert and may serve as a coach and mentor to junior staff.

Principal Duties and Responsibilities
  • Lead the ongoing configuration, implementation, and maintenance of the electronic Trial Master File system in collaboration with the TMF group
  • Lead the development and implementation of internal processes related to GCP and SOPs
  • Serve as subject matter expert concerning GCP and provide quality and compliance guidance to internal clinical personnel; train and mentor staff
  • Perform quality control review of key clinical documents
  • Assess compliance of clinical investigator sites, vendors, study activities, data, reports, and submissions against the International Conference of Harmonization (ICH), applicable government agency regulations/ guidelines, as well as internal policies, procedures and industry standards
  • Lead data integrity processes and assure maintenance of data integrity standards
  • Collaborate with EMEA legal teams in the coordination of General Data Protection Regulation (GDPR)
  • Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviation with projects/ products, to appropriate leaders and colleagues
  • Collaborate with relevant internal functions to develop a GCP inspection readiness program; liaise with cross-functional teams to support audit and inspection activities; assist with inspection activities for GCP inspection at company and investigator sites.
  • Develop and deliver GCP and other relevant training

Requirements / Qualifications
  • A Bachelor’ s degree in a scientific discipline or health related field (e.g., nursing, pharmacy, physician’ s assistant) with an advanced degree preferred.
  • Candidates should have a minimum of 10+ years of clinical research experience (or equivalent).
  • Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing clinical trial conduct.
  • Very strong verbal, written and presentation skills are required.
  • Experience of leading of a matrixed cross-functional team.
  • Ability to work independently and in a team environment.

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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