Sr. Clinical Trials Manager

Guardant Health   •  

Redwood City, CA

8 - 10 years

Posted 184 days ago

Company Description

ABOUT OUR COMPANY

We believe conquering cancer is a big data problem. That’s why we built the world’s leading comprehensive liquid biopsy. This non-invasive tool for accessing and sequencing tumor DNA is used by thousands of oncologists to help tens of thousands of advanced cancer patients. We believe the boom in cancer data acquisition we helped launch will drive important discoveries and new products. We’re working on some exciting ones, including in early detection, where the impact on patients can be profound. We’ve raised more than $500 million from investors including Sequoia Capital, Khosla Ventures, OrbiMed, and SoftBank.

Job Description

  • Assists in the process of protocol finalization and manages all aspects of study execution.  Uses operational and therapeutics expertise to optimize trial design and execution. 
  • Manages operational plans and timelines to achieve on-time enrollment and study completion. Identifies barriers to timely and successful study execution and proposes solutions to same, with regular reporting of study performance metrics.
  • Manages Contract Research Organization (CRO) and Pharmaceutical Company relationships and 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.
  • Assures compliance with all regulatory requirements.  Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management.
  • Drives data collection, clinical trial database construction, and assists with necessary audits of data to ensure data validity. 
  • Develops and manages study budget and maintains it within financial goals; reviews and approves clinical invoices against approved budget.
  • May have direct reports such as CTAs and/or CRAs. 
  • Maintains proficiency in understanding of molecularly targeted therapies in oncology and an in-depth knowledge of genomic alterations in different cancers.
  • 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. 3+ years direct trial management experience, preferably including clinical team management.
  • Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
  • Clinical experience, oncology, cancer center, inpatient or outpatient or physician office setting experience a plus
  • Practical experience with clinical studies involving in vitro devices (IVD) a plus
  • Practical experience with Companion Diagnostic (CDx) studies is highly preferred
  • 3+ years of clinical trial experience as a CRA/Senior CRA in Pharmaceutical, Biotech or CRO company is highly 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 25%-50% of the time.
  • 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