Associate Director, Clinical Studies

Company: Guardant Health
Location: Redwood City
Posted on: August 1, 2022

Job Description:

Job Description

Essential Duties and Responsibilities:

--- - - - - - Responsible for coordinating all aspects of study execution including start-up, maintenance, and close-out for an investigational site.

--- - - - - - 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, etc.

--- - - - - - Oversee research use only sample processing operations.

--- - - - - - Implement automated processes to help Guardant Health investigational sites scale for multi-site multi-product large scale clinical trial execution

Skills:

--- - - - - - 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