Date: 12-Apr-2011
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Senior Manager/Director Quality Assurance, Good Clinical Practices
Quality Assurance (QA) Sr. Manager/Director, GCP, personally conducts or supervises conduct of:
· QA audits of MDCO clinical trials, including but not limited to, clinical investigator site audits, vendor audits, clinical document audits and process audits, to verify adherence to good clinical practices (GCP) and MDCO quality standards
· QA audits of pre-clinical facilities, studies and activities, to verify adherence to good laboratory practices (GLP)
· QA audits of MDCO pharmacovigilance (PV) activities, including PV system, process and document audits
In addition, QA Sr. Manager/Director:
· Manages program/project-specific audit plans
· Manages contracts and performance of vendors conducting audits on behalf of MDCO
· Participates in the preparation of the annual audit plan as well as project-specific quality assurance plans
· Acts as a subject matter expert for GCP, GLP and/or PV issues and provides expert support to project teams
· Provides reports to the management and the teams on the results of MDCO audit program
· Provides training, as needed, to clinical research associates and clinical site personnel on the good clinical practice regulations and guidelines
· Provides support during regulatory and health authority inspections of MDCO clinical trials and/or clinical investigator sites participating in MDCO trials.
Educational/Experiential Requirements
BS or BA in life sciences. Preferred advanced degrees such as: RN, PharmD, MS, Quality
At least 10 years of experience in clinical research or related field, of which at least 5 years’ experience in QA auditing. GCP and another GxP (GLP, PV, computer system validation (CSV)) QA auditing experience required.
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Thank you,
BioTech FYI Center
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