Company Description|Job Description
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
Guardant Health is looking for a highly motivated Clinical Study Manager (CSM) to oversee the day to day operations of clinical studies conducted in partnership with BioPharma clients. The hiring team is looking for a seasonedCSMwho hasa proven track-record managing clinical studies. The CSM:
- Manages operational scope & plans to achieve milestones on-time. Identifies barriers to timely & successful study execution & proposes solutions to same, with regular reporting of study performance metrics.
- Works cross-functionally with other Guardant Health departments (such as BioPharma Business Development, Regulatory Affairs, Client Services, Laboratory) to execute study protocols in accordance with Good Clinical Practices (GCPs)
- Assists with training & oversight of investigative site staff, & provides ongoing educational assistance to assure compliance with study protocols.
- Ensures compliance with applicable regulatory requirements.
- Consults with cross-functional teams on data collection, regulatory questions, & protocol execution as it pertains to the Guardant Health assay.
- Assists with Scope of Work (SOW) review & provides input on Clinical Development resourcing needs. Ensures resourcing & Clinical Development activities remain within SOW. May approve clinical invoices against approved budget
- Coordinates the creation & finalization of a Data Transfer Agreement (DTA) between Guardant Health & BioPharma Partners.
- 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. Creates Purchase Orders, receives, files & tracks invoices & facilitates payment through finance.
- 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
- 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
- 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
Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & biohazard material in the laboratory environment. Ability to sit for extended periods of time.
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.
All your information will be kept confidential according to EEO guidelines.
Please visit our career page at:http://www.guardanthealth.com/jobs/