Program Manager Lead - Clinical Quality Assurance

-A life sciences consulting firm is looking for a program manager who will be responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and significant experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities independently.
-The program manager will provide guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations, liaise with various R&D functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance.
-Manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and the client’s procedures; assess impact of audit findings on subject safety, data integrity and business operations.
-The consultant must have strong GCP experience. GCP Quality Assurance registration/certification is preferred. Also must have experience supporting complex clinical programs with multiple Clinical Research Studies, CRO, and site management.

**This is a 6 month project with high probability of extension