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.
ABOUT THE ROLE
At Guardant Health, we are committed to positively and significantly impacting patient health through technology breakthroughs that pointedly address long-standing unmet needs in oncology. As the leader in the liquid biopsy field Guardant Health has information about the mutational landscapes of over 30,000 patients.
The Clinical Trial Manager (CTM) is responsible for the successful execution of clinical trials from the protocol concept through publication, ensures completion of study deliverables, typically works on studies that are internally driven or are part of key collaborations, proactively identifies and resolves clinical project issues and participates in process improvement initiatives as required. The CTM engages with study investigators, vendors and external stakeholders as a member of the Clinical Development team.
- Assists in the process of protocol finalization and manages all aspects of study execution. Uses operational and therapeutic 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. Possesses expert knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
- Drives data collection, oversees clinical trialdatabaseconstruction, 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
- 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 per Guardant Health policies
You are a seasoned clinical operations professional with a proactive mindset and an ability to find great solutions to complex problems. You have had experience in the oncology space in pharmaceutical or biotech development. You work very well with minimal direction and seek out answers or collaborations where you need them.
- Bachelor’s degree or equivalent combination of education/experience in science or health-related discipline
- Minimum of 4 years of clinical trialexperience in Pharmaceutical, Biotech or CRO company. Minimum of 2 years’ direct trial management experience
- 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
- 2+ years of clinical trialexperience as a CRA/Senior CRA in Pharmaceutical, Biotech or CRO company is required
- Solid organizational and business assessment skills is required
- Demonstrated ability to develop positive working relationships with individuals and teams internally and externally
- Ability to work independently as well as part of a cross functional team
- Excellent problem solving ability necessary
- Excellent written and verbal communication skills
- Maintain therapeutic knowledge
- Flexible attitude to adjust to changing client and regional needs
- Ability and willingness to travel 25%-50% of the time
- Must have excellent knowledge of MS Office and clinical trials software
We would like to talk with you about our exciting projects we currently have ongoing. Please see guardanthealth.com/jobs for more information and to apply.