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Clinical Project Manager

Company: Guardant Health, Inc.
Location: Redwood City
Posted on: June 9, 2021

Job Description:

About the 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. Guardant Health's Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to 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, Guardant360CDx and GuardantOMNI, for patients with advanced cancer, which fuel its LUNAR development programs for cancer recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 7,000 oncologists, over 50 biopharmaceutical companies and at all 27 of the National Comprehensive Cancer Network centers.

The Clinical Project Manager manages all aspects of non-registrational clinical studies (primarily those identified by Medical Affairs) including contracting, pricing, study set up (internal and external), study initiation, sample tracking, and results reporting

Job Description

  • Manages all aspects of study execution including contracting, pricing, study set up (internal and external), study initiation, sample tracking, and results reporting
  • Liaises cross functionally across the business including with members of legal, research operations, CLIA lab operations, strategic management, and biopharma
  • Manages operational plans and timelines to achieve on-time study activation 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), study site personnel (e.g. at academic centers), 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 Guardant Health guidelines and SOPs. Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management is preferred.
  • 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 according to Guardant Health policies.

Qualifications

  • Bachelor's degree (or higher) in science or health-related discipline
  • 3+ years of clinical trial experience in Pharmaceutical, Biotech or CRO company.
  • Understanding/knowledge of GCPs, ICH, and regulatory requirements
  • Clinical experience, oncology, cancer center, inpatient or outpatient or physician office setting experience a plus
  • Solid organizational and business assessment skills is required
  • Demonstrated ability to develop positive working relationships with individuals and teams internally and externally
  • Excellent problem-solving ability necessary
  • Excellent written and verbal communication skills in English
  • Maintain therapeutic knowledge
  • Flexible and solution seeking attitude
  • 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
  • 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

#LI-RL1

All your information will be kept confidential according to EEO guidelines.

Keywords: Guardant Health, Inc., Redwood City , Clinical Project Manager, Other , Redwood City, California

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