Job Details

  • Title: Assistant Clinical Inspection Readiness Leader
  • Code: RCI-03242
  • Location: Bridgewater New Jersey (NJ) 08807
  • Posted Date: 11/24/2020
  • Duration: 5 Months
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  Job Description

The Assistant Clinical Inspection Readiness Leader (Assistant CIRL) is part of the Clinical Quality Performance Team, under the Quality umbrella, and supports the Clinical Inspection Readiness Leader (CIRL) as part of the Inspection Readiness and PAI Preparation teams.

The Assistant CIRL is responsible to support process and tool development/improvement/management initiatives and activities related to Clinical Inspection Readiness (IR), Pre-Approval Inspection (PAI) Preparation and PAI support and provides support to gathering/compilation of best practices and lessons learned.

Knowledge of Research & Development with experience in clinical operations, preferably within clinical trial management and/or GCP Quality and FDA/EMA GCP inspections.  Knowledge of GCPs, ICH and SOPs. Experience with Sharepoint sites (developing & maintaining), Excel (good technical abilities), and Microsoft TEAMS

 

The following skills are also of particular importance:

  • Quality focused with a high degree of personal accountability and commitment
  • Knowledge of international good clinical practices (ICH) and current regulatory requirements (FDA, EMEA) related/ applicable to the conduct of clinical trials, understanding of FDA Compliance Manual & EMA Compliance Manual
  • Results driven with attention to detail and quality while overseeing and connecting with contributing stakeholders
  • Excellent interpersonal and communication skills (written and verbal)
  • Ability to drive results within established timelines
  • Works proactively and takes initiative
  • Ability to multi-task, handling a wide range of small, medium and long-term assignments in parallel and dealing with urgent issues as they arise with ability to prioritize assignments in accordance with assigned project deadlines
  • Expert experience in various software and tool development (e.g. excel, databases, others)

Education:
  • Associate degree or higher in a relevant scientific/health-related field.
Minimum of 4 years experience in the pharmaceutical industry, with a minimum of 2 years experience in GCP clinical and/or quality operations-related roles (e.g., direct study management, monitoring, auditing)

Knowledge And Skills Desirable But Not Essential:
  • Experience with FDA, EMA or other GCP regulatory inspections of sponsor, investigator sites, or CROs
  • Experience working within a global team/environment
  • Experience in web design and build