Associate Director, Clinical Studies
Company: Guardant Health
Location: Redwood City
Posted on: August 1, 2022
Essential Duties and Responsibilities:
--- - - - - - Responsible for coordinating all aspects of study
execution including start-up, maintenance, and close-out for an
--- - - - - - Works cross-functionally with other Guardant Health
departments (such as Clinical Trial Operations, Bioinformatics,
Clinical Operations, Regulatory Affairs, Client Services, etc.) to
ensure timely execution of -study -protocols in accordance with
Good Clinical Practices (GCPs).
--- - - - - - Primary operational point of contact for Clinical
Trial Operations regarding execution of diagnostic study
collaborations with pharmaceutical partners.
--- - - - - - Identify barriers to timely and successful -study
-execution and propose creative solutions in order to deliver
project milestones. -
--- - - - - - Assess feasibility of -study -timelines and
pharmaceutical partner requirements.
--- - - - - - Oversee -study -monitoring to ensure compliance to
the -study -monitoring plan by planning monitoring visit schedule,
reviewing and approving monitoring reports, and providing guidance
to Clinical Operations for closure of monitoring findings.
--- - - - - - Responsible for -training of investigative site staff
and providing ongoing educational assistance to ensure compliance
with -study -protocol and applicable regulatory requirements. -
--- - - - - - Manage Clinical Study Coordinators and CSC Assistants
to foster departmental growth, consistency, and compliance.
--- - - - - - Develop and collaborate on -study -materials
including Protocols, SIV slides, Lab Manuals, Communication Plans,
--- - - - - - Oversee research use only sample processing
--- - - - - - Implement automated processes to help Guardant Health
investigational sites scale for multi-site multi-product large
scale clinical trial execution
--- - - - - - Demonstrated people management skills
--- - - - - - Demonstrates effective writing skills. (i.e. clear,
concise, and well-organized)
--- - - - - - Understands changes in work tasks, situations, and
environment as well as the logic or basis for change.
--- - - - - - Able to thrive with minimal supervision
--- - - - - - Able to drive a resolution for project-related
problems while prioritizing workload
--- - - - - - Efficient and effective work habits in a matrix
environment, internally and externally.
--- - - - - - A flexible attitude to adjust to changing needs
--- - - - - - Excellent knowledge of MS Office as well as project
management and clinical trials software.
Keywords: Guardant Health, Redwood City , Associate Director, Clinical Studies, Executive , Redwood City, California
Didn't find what you're looking for? Search again!