Location: Europe, Middle East & Africa-Russia-Smolensk Region-Smolensk - Marshala
Closing Date: 29 Oct 16
Type: Full Time
Salary (£): On Application
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. ...
PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 44 countries and more than 11,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com
Clinical Review Specialist
The objective of a Clinical Review Specialist is to review patient data in accordance with Good Clinical Practice, Standard Operating Procedures/Working Practice Documents and Data Validation Manuals (DVMs). Clinical Review Specialists will be expected to liaise with colleagues in other functional groups as required, and to communicate with management for all data review activities within their allocated studies.
Duties and Responsibilities (according to relevant guidelines, laws and SOP's)
• Reviews patient data in accordance with the Manual Data Review Plan in the DVM.
• Uses medical knowledge to clarify and resolve issues with clinical data (e.g. adverse events, concomitant medications, concurrent medical conditions etc.) gathered during lifecycle of clinical trials.
• Identifies potential data issues and works with PPD team and study sites to resolve. Ensures data accuracy according to departmental operating procedures.
• Ensures applicable data review activities are conducted accurately, and all related deliverables are completed to quality expectations, within budget and on time. Provides support, guidance and direction on clinical data review to the CDM project team.
• To ensure that all work conducted is completed to the acceptable quality in accordance with SOPs/WPDs, Protocol and DVM.
• To ensure all required documentation, as defined in the SOPs/WPDs and DVM, is created and filed correctly.
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