Associate Director Clinical Compliance #3741 - Raleigh-Durham, United States - GRAIL

Description

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit

Grail'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

• 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

Preferred Qualifications

• 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%

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

GRAIL is an Equal Employment Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.