Full-Time

Associate Director Clinical Compliance

GRAIL

GRAIL

1,001-5,000 employees

Designs cancer screening tests

Data & Analytics

$159,000 - $199,000

Annual Bonus, Incentive Plan, Long-Term Incentive Plan

Senior, Expert

Menlo Park, CA, USA

Required Skills
Management
Requirements
  • B.S./B.A. in a science or related life science field or equivalent
  • 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 conduct
  • Understanding 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%
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

GRAIL's mission is to detect cancer early, when it can be cured. They are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care.

Company Stage

M&A

Total Funding

$11B

Headquarters

Menlo Park, California

Founded

2016

Growth & Insights
Headcount

6 month growth

5%

1 year growth

13%

2 year growth

26%

Benefits

Outstanding People - Join a team of passionate and dedicated professionals, committed to collaboration, education, and proactive problem-solving.

Strong Compensation - We offer competitive salaries and savings plans to provide for long-term financial planning.

Complete Health Coverage - Take advantage of comprehensive health coverage, with medical, dental and vision, to keep you and your family healthy.

Work-Life Balance - Make everyday life more manageable with flexible time off – we trust you to do great work and take time for yourself.