Company Description|Job Description
ABOUT OUR COMPANY
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 cancer, 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.
At Guardant Health, we are committed to positively & 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.
Guardant Health is looking for a highly motivated Clinical Trial Manager (CTM) to oversee the day to day operations of Investigator Sponsored Trials (ISTs) for the LUNAR program.The hiring team is looking for seasoned CTMs or experienced Clinical Research Associates (CRAs) who have managed clinical trials & are looking to transition to a full-time trial management position.The CTM:
- 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.
- Effectively communicates with external Key Opinion Leaders (KOLs) & Investigators participating in Guardant Health trials
- Works cross-functionally with other Guardant Health departments (such as Medical Affairs, Regulatory Affairs, Client Services, Laboratory) to execute study protocols
- Assists with site training & management, & provides ongoing educational assistance to assure compliance with study protocols.
- Ensures compliance with applicable regulatory requirements.
- Consults with Investigators on data collection, regulatory questions, & protocol execution as it pertains to the Guardant Health assay.
- Leads budget review & negotiation. Manages study budget & maintains it within financial goals; reviews & approves clinical invoices against approved budget.
- Drives execution of study contracts between Investigative team & the Guardant Health legal team
- 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 of clinical trial experience as a CTM or CRA with trial management experience is preferred
- Experience on Investigator Sponsored Trials (ISTs), a plus
- Strong understanding of GCPs, ICH, & knowledge of regulatory requirements
- Clinical experience, oncology, cancer center, inpatient or outpatient or physician office setting experience a plus
- Solid organizational & business assessment skills is required
- Demonstrated ability to develop positive working relationships with individuals & teams internally & externally
- Demonstrated problem-solving skills
- Excellent written & verbal communication skills in English
- Therapeutic knowledge
- Flexible & solution seeking attitude
- Ability & willingness to travel 10%-15% 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
- Detail 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.