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 and advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and 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 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.
Guardant Health is looking for an experienced Clinical Data Manager to bring their motivation and expertise to our expanding portfolio of studies. The hiring team is looking for someone who has developed and 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 and external stakeholders to build and maintain procedures and processes. The Clinical Data Manager:
- Oversees operational scope and plans to achieve milestones on-time. Identifies barriers to timely and successful data transfers and proposes solutions to same.
- Effectively communicates both internally and externally to align on Data Transfer Agreements (data deliverables and timelines)
- Works cross-functionally with other Guardant Health departments (such as Regulatory Affairs, Bioinformatics, Laboratory) to ensure on-time and compliant data transfers.
- Identify and build CRF/EDC systems to support CDx study regulatory reports.
- Plan, manage and coordinate all data management activities for assigned program(s) to ensure consistency of clinical data standards across programs
- Author and 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 and clinical database specifications
- Manage timelines across multiple internal and external cross-functional teams.
- Brings a strong understanding of GCP’s, ICH, and knowledge of regulatory requirements in support of successful CDx submissions and an ability to communicate same to build internal programs
- Drive for results (demonstrates interest and 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, and pragmatic approach to tasks, with good attention to detail.
- Solid analytical and problem-solving skills
- Strongunderstanding of GCPs, ICH, and knowledge of regulatory requirements
- Solid organizational and business assessment skills is required
- Demonstrated ability to develop positive working relationships with individuals and teams internally and externally
- Excellent written and verbal communication skills in English
- Must have excellent knowledge of MS Office as well as project management and clinical trials software
- Driven to make a positive impact in cancer diagnosis and 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 and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and 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 and will not be discriminated against on the basis of disability.
All your information will be kept confidential according to EEO guidelines.