Company Description|Job Description
ABOUT OUR COMPANY
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 an experienced Clinical Data Manager, Companion Diagnostics (CDx) to bring their motivation & expertise to our expanding portfolio of CDx studies.The hiring team is looking for someone who has developed & executed the full scope of GCP Data Management processes in support of IDE studies.
The successful candidate is a highly organized individual who will work collaboratively with internal & external stakeholders to build & maintain procedures & processes.The Clinical Data Manager, CDx:
- Oversees operational scope & plans to achieve milestones on-time. Identifies barriers to timely & successful data transfers & proposes solutions to same.
- Effectively communicates both internally & externally to align on Data Transfer Agreements (data deliverables & timelines)
- Works cross-functionally with other Guardant Health departments (such as Regulatory Affairs, Bioinformatics, Laboratory) to ensure on-time & compliant data transfers.
- Identify & build CRF/EDC systems to support CDx study regulatory reports.
- Plan, manage & coordinate all data management activities for assigned program(s) to ensure consistency of clinical data standards across programs
- Author & maintain (in Trial Master File (TMF)) data management documentation from study start-up to database lock such as SOPs, process flow maps, data management plans, case report forms, data transfer specifications & clinical database specifications
- Manage timelines across multiple internal & external cross-functional teams.
- Brings a strong understanding of GCP's, ICH, & knowledge of regulatory requirements in support of successful CDx submissions & an ability to communicate same to build internal programs
- Drive for results (demonstrates interest & ability to learn new things, takes initiative, welcomes problems as challenges, finds solutions to technical problems, persists in the face of adversity).
- Bachelor's degree (or related experience) in a related discipline
- Demonstrated ability to execute as a data manager for CDx studies
- Systematic, structured, & pragmatic approach to tasks, with good attention to detail.
- Solid analytical & problem-solving skills
- Strongunderstanding of GCPs, ICH, & knowledge of regulatory requirements
- Solid organizational & business assessment skills is required
- Demonstrated ability to develop positive working relationships with individuals & teams internally & externally
- Excellent written & verbal communication skills in English
- 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
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/