Company Description|Job Description
Guardant Healthis a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. The Guardant Health Oncology Platform is designed to leverage our capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs.
In pursuit of our goal to manage cancer across all stages of the disease,Guardant Healthhas launched two liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, & is developing programs for recurrence & early detection in early stage cancers, called Project LUNAR. Since its launch in 2014, Guardant360 has been used by more than 5,000 oncologists, over 40 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
- Assists in the process of protocol finalization & manages all aspects of study execution.Uses operational & therapeutics expertise to optimize trial design & execution.
- Manages operational plans & timelines to achieve on-time enrollment & study completion. Identifies barriers to timely & successful study execution & proposes solutions to same, with regular reporting of study performance metrics.
- Manages Contract Research Organization (CRO) & Pharmaceutical Company relationships & contracts for study execution where applicable.
- Assists with management and/or execution of site training, & ongoing educational interventions to assure compliance with study protocols.
- Assures compliance with all regulatory requirements.Knowledge of GCP, ICH guidelines & regulatory requirements for clinical trial management.
- Drives data collection, clinical trial database construction, & assists with necessary audits of data to ensure data validity.
- Develops & manages study budget & maintains it within financial goals; reviews & 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 & an in-depth knowledge of genomic alterations in different cancers.
- Manages & controls expenses according to Guardant Health policies.
- Bachelor's degree (or higher) in science or health-related discipline
- 5+ 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, & 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
- Practical experience with EHR & Real World Data is a plus
- 3+ years of clinical trial experience as a CRA/Senior CRA in Pharmaceutical, Biotech or CRO company is highly preferred
- Solid organizational & business assessment skills is required
- Demonstrated ability to develop positive working relationships with individuals & teams internally & externally
- Excellent problem solving ability necessary
- Excellent written & verbal communication skills in English
- Maintain therapeutic knowledge
- Flexible & solution seeking attitude
- Ability & willingness to travel 25%-50% of the time.
- Must have excellent knowledge of MS Office as well as project management & clinical trials software
- Driven to make a positive impact in cancer diagnosis & 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
All your information will be kept confidential according to EEO guidelines.
Guardant Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status & will not be discriminated against on the basis of disability.