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Job Details

Clinical Trial Quality Assurance Manager

Company: MSI Group Limited
Location: Reading
Reference: VR0278
Closing Date: 19 Jun 17
Type: Contract
Salary (£): Competitive
Benefits: Home Based flexibility

Job Summary:

Home Based Flexibility


Our Client, a globally recognized pharmaceutical company based in the UK is actively searching for a skilled professional to fill the role of Clinical Trial Quality Assurance Manager.

Key responsibilities:

• Develops and executes the Integrated Quality Plan (IQP), with guidance from the QP&S IQP leader and/or the Program Leader

•Develops, maintains and execute trial oversight activities for assigned trials/indications to ensure quality in the execution of clinical trials, compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness.

• Actively participates in pre-study activities, contributing to the identification of key risks in the clinical protocol and advising clinical team members on effective mitigation strategies.

• Ensures that selection of investigator sites balances benefits against potential risks and that rationale for decisions are well documented.

• Monitors risks and mitigations during study execution. Prepares periodic reports assessing critical to quality parameters for the trial and reviews these reports with applicable clinical team members to evaluate pre-defined areas of risk and/or identify new areas of risk.

• Responds independently to GCP-related compliance inquiries from clinical team members.


Education/Skills Required:

• A minimum of a Bachelor's Degree is required, preferably in a science or technical related discipline 
• A minimum of 8 years of relevant professional experience is required 
• A minimum of 4 years' experience working in a R&D environment in the pharmaceutical/, Medical device and/or consumer industries are required 
• Knowledge of the drug development process and good knowledge of worldwide GCP (Good Clinical Practice) is required 
•Experience with regulatory submissions (NDA, BLA) is preferred 
• Knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development is required


Quality, Quality Assurance, GCP, IQP, Compliance, Quality Trial, Regulatory, Home Based flexibility 

Regulatory Requirements

Apply for this job: Clinical Trial Quality Assurance Manager

Contact Information:

Address:  Head Office
3rd Floor East, Cottons Centre, 47/49 Hays Lane London SE1 2QE
Tel:  02079401985
Fax:  02079909763
Website:  Visit Our Web Site

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