Sr. Manager GCP / San Francisco / $130k

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 25% of the time

Requirements:

* At least 4-6 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