- Provide day to day clinical compliance support for one or more studies to ensure compliance of clinical trial sites and processes against ICH E6 (GCP) and applicable regulations
- Revise, develop, and maintain Clinical Quality Management System procedures through a proactive knowledge management framework that incorporates learnings from internal and external inspections and compliance trends
- Help define, collect, and report compliance-related metrics
- Review SOPs related to clinical trial conduct, ensuring they are complete, consistent and compliant with applicable laws, regulations, and standards
- Participate in the creation of training materials and delivery of training designed to ensure that compliance requirements are understood and implemented
- Conduct clinical compliance internal audits, and clinical supplier audits as needed
- Assist in the hosting of inspections and audits; creating responses to audit findings; tracking progress to ensure resolution; and identifying lessons learned
- Lead GCP Inspection Readiness activities for study teams and supporting departments
- B.S./B.A. in a science or related life science field or equivalent; advanced scientific degree preferred.
- 10+ years experience in any of the following industries: direct In Vitro Diagnostic, medical device or pharma industry.
- Experience supporting regulatory inspections such as BIMO. Expert knowledge of applicable regulations and standards as they relate to clinical trial conductUnderstanding of appropriate global medical device/IVD requirements, such as: ICH E6 (GCP), European Union (ISO 20916, ISO 14155, IVDD/IVDR), US [21 CFR Part 812 and Part 11].
- Experience managing GCP quality processes such as managing Quality Events and CAPAs; and participating in risk management activities.
- Conducting GCP audits of internal processes, clinical investigator sites, and clinical service vendors.
- Demonstrated ability to initiate process improvements and take initiative.
- Strong influencing skills, with the ability to work collaboratively and cross functionally, within a constantly evolving fast-paced startup environment.
- Ability to drive and manage change with a positive approach.
- Potential travel of up to 10%
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Associate Director Clinical Compliance #3741 - Raleigh, United States - BioSpace
Description
Job DetailsGrail's Clinical Quality Assurance (CQA) department is seeking a compliance expert to support compliant conduct of Grail's clinical studies and to support Grail's partnerships with pharmaceutical companies for companion diagnostic (CDx) tests.
The Associate Director will work cross-functionally to manage Grail's Clinical Quality Management System; conduct gap assessment and audit of clinical procedures and practices, support remediation activities, and partner with clinical study teams to ensure compliance.
Responsibilities
Associate Director Clinical Compliance #3741 professionals in Raleigh
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Stephanie Ladd
Senior Clinical Research Professional