Senior Manager, Clinical Trials

Company Description

Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched Guardant360®, Guardant360 CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantOMNI® tests for advanced stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening.

Job Description

• Assists in the process of protocol finalization and manage all aspects of study execution.  Uses operational expertise to optimize trial design and execution.  
• Manages operational plans and timelines to achieve on-time study completion. Identifies barriers to timely and successful study execution and proposes solutions to same, with regular reporting of study performance metrics (vendor management, analysis and data transfer). 
• Manages Contract Research Organization (CRO) contracts for study execution where applicable.  
• Assists with management and/or execution of site training, and ongoing educational interventions to assure compliance with study protocols which may include biospecimen acquisition and handling.
• Assists with prioritization and timeline management, manages internal stakeholders and communications around all aspects of biospecimen management
• Assures compliance with all regulatory requirements.  Prior knowledge and experience of GCP, ICH guidelines and regulatory requirements for clinical trial management is a bonus.
• Drives data collection, clinical trial database construction, and assists with necessary audits of data to ensure data validity.  
• Develops and manages study budget for clinical trial and maintains it within financial goals; reviews and approves clinical invoices against approved budget.
• Manages and controls expenses according to Guardant Health policies.

Qualifications

• Bachelor’s degree (or higher) in science or health-related discipline
• 7+ years of clinical trial experience in Pharmaceutical, Biotech, or CRO company. Preferred direct trial management experience, preferably including CRO management.
• Strong understanding of GCPs, ICH, and knowledge of regulatory requirements is of benefit
• Practical experience with clinical studies involving in siteless methodologies or virtual recruitment preferred
• Solid organizational and business assessment skills is required
• Demonstrated ability to develop positive working relationships with individuals and teams internally and externally
• Excellent problem-solving ability necessary
• Excellent written and verbal communication skills in English
• Maintain therapeutic knowledge
• Flexible and solution seeking attitude
• Ability and willingness to travel 20% of the time (post-pandemic).
• Must have excellent knowledge of MS Office as well as project management and clinical trials software
• Driven to make a positive impact in cancer diagnosis and treatment
• Detailed oriented with an appetite to drive tasks to completion
• Ability to work well in a rapid-pace startup environment
• Ability to work well in a group
• Ability to work independently, with minimal supervision

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Additional Information

Hybrid Work Model: At Guardant Health, we have defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.

The US base salary range for this full-time position is $104,160 to $160,800. The range does not include benefits, and if applicable, bonus, commission, or equity. The range displayed reflects the minimum and maximum target for new hire salaries across all US locations for the posted role with the exception of any locations specifically referenced below (if any).

Within the range, individual pay is determined by work location and additional factors, including, but not limited to, job-related skills, experience, and relevant education or training. If you are selected to move forward, the