Sr. Manager GCP

This is an exciting new opportunity with a thriving mid sized Pharma company. We are looking for a QA GCP Manager/Senior Manager who will be responsible for assisting the Director in implementing GCP Quality Assurance programs for the conduct of clinical trials, including conducting and reporting internal/external audits, clinical study reports and other documents; providing compliance advice to clinical project teams and assisting with other departmental needs. A few requirements are as follows; * Plan, conduct and report audits of clinical investigator sites, vendors, clinical study reports, trial master files and other clinical documents (e.g. CTD sections) * Maintenance of appropriate GCP audit documentation * Follow up on audit findings and corrective actions to closure * Identification of compliance issues through the use of internal and external audit programs to minimize regulatory and business risk * Travel, as required, up to approximately 30% of the time Requirements: * At least 4 years Clinical QA experience, including internal/external GCP audits, is required * Demonstrate a thorough knowledge of GCP regulations and guidelines * Excellent written, oral and interpersonal skills If you are interested in being submitted for the QA GCP Sr. Manager role, please send you information to b.ross(@)realstaffing.com Thank you for your time and consideration!

To find out more about Real please visit www.realstaffing.com [1]

Links:
------

[1] http://www.realstaffing.com