Consultant, Clinical Quality Assurance and Early Access Programs

Savara is seeking a Consultant of Clinical Quality Assurance and Early Access Programs to support the quality oversight and management of Good Clinical Practices (GCP) activities related to the Early Access Program (EAP), a program developed in order to provide investigational product to patients while the pivotal data from the IMPALA-2 Phase 3 clinical trial is under review by Health Authorities. This consultant will be responsible for vendor oversight, review of key project plan and dcouments, generation and management of associated quality events. This cnonsultant will identify risks, resolve issues, and escalate appropriately.

This contract is expected to be 120-170 hours per month for a duration of 12 months.

Working as a member of the Early Access Program (EAP) Team, drive strategy and execution of the following:

• Provide Clinical Quality Assurance (GCP) leadership and Subject Matter Expertise (SME) to the Early Access Program (EAP) Team
• Perform a gap assessment on vendors and identify a remediation plan as needed
• Assess the medical review process for proper documentation
• Provide strategy and execution in the anticipated transition of patients to commercial product (depending on Health Authority approval)
• Generate and coordinate appropriate and timely documentation of quality event management, including corrective action and preventive action (CAPA) plans, as necessary
• Author, revise and maintain QA Standard Operating Procedures (SOPs) as necessary
• Provide Clinical Quality Assurance SME to reviews of clinical protocols, amendments, informed consent forms, and other related documents, including associated regulatory submission documents
• Plan, conduct, and/or assist in internal and external service provider audits. Review audit reports, and any corresponding corrective and preventative actions for adequacy
• Previous experience providing GCP QA oversight to EAPs is strongly preferred.
• The consultant can be located anywhere within the U.S.

This is a consultant role.

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