Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

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

Requirements:

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
SE1 1QL
England
Tel:  02079401985
Fax:  02079909763
Website:  Visit Our Web Site

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.