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Clinical Quality Manager (GCP)

Company: Beacon Hill Staffing Group - Pharma
Location: Durham
Posted on: June 18, 2019

Job Description:

Plan and lead GCP audits (international and domestic), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks. Assess GCP compliance risk areas and develop and implement risk mitigation measures. Ensure compliance with companys procedures and regulatory requirements. Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports). Review and provide input in to non-clinical documentation (e.g. protocols, study reports). Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies. Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers. Provide guidance, interpretation and information on GCP regulations, standards and quality systems. Develop and implement standards, policies and procedures for GCP regulatory compliance. Develop and measure quality metrics to drive consistent quality standards relating to GCP activities. Experience, Education and Specialized Knowledge and Skills Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks. Masters Degree preferred with minimal 10 years experience in Biotech or Pharma and 5+ years experience in Quality Systems related to GCP. Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement. Extensive experience auditing clinical CROs, clinical sites and investigator sites. Understanding of domestic and international regulatory requirements. Outstanding communication skills (interpersonal, verbal and written). Proven track record of industry success. Strong leadership and management skills. Excellent teamwork and collaboration skills. Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.

Keywords: Beacon Hill Staffing Group - Pharma, Greenville , Clinical Quality Manager (GCP), Executive , Durham, North Carolina

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