Clinical Trial Manager

Organization
GRAIL, Inc.
Job Location
Redwood City, CA
Job Description

The Clinical Trial Manager will provide overall day-to-day leadership in clinical study operations for diagnostic product development in support of GRAIL clinical development and commercial strategies. The key accountability centers on rigorous, compliant and timely execution of clinical studies and quality delivery of study results.   

  • Manage all clinical operational aspects of study, including assessment of feasibility; development and management of study timelines and metrics; vendor specifications and selection; review and monitoring of vendor reports, invoices, and metrics; study-specific training and leadership of clinical research staff, including CRO, CTAs, sites and other contract personnel; study-specific meetings, management of site and remote EDC monitoring of study data.

  • Prepare and/or review study-related documents (e.g., site-specific informed consent, investigator contracts, and site payments, study tools/worksheets, monitoring plan, laboratory and sample processing manual, CRF completion guidelines, site monitoring report, etc.).

  • Provide operational insights into clinical trial design, including clinical protocols, amendments, informed consent forms, study guides, case report forms.

  • Participate in identification, selection, and monitoring performance of investigational sites for clinical studies; develop and maintain strong working relationships with investigators and study staff

  • Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures.

  • Track and report on progress of study according to timelines; review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.

  • Develop and manage study budget and maintains it within financial goals; review and approve clinical invoices against approved budget.

  • Be a subject matter expert on clinical operations and assist in the training of CRAs, CTAs and CRO personnel on protocols and practices

Requirements

PREFERRED BACKGROUND

  • 6+ years experience with managing clinical trials in either sponsor or CRO organizations, with a strong track record of successful trial initiation and execution.

  • Bachelor’s degree or equivalent in the life sciences or related field required; advanced degree preferred.  Additional coursework in clinical trial planning and execution strongly desired.

  • Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable.

  • Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements.

  • Experience managing vendors, including performance assessments and total financial management (invoice review, change order management, budget reforecasting, etc.)

  • Working experience with an electronic data capture system and CTMS system

  • Proficient with office automation tools, such as Microsoft Office and Google toolkit.

  • Strong interpersonal communication (written and verbal), and organizational skills

  • Able to motivate a team to work effectively under a fast-paced and changing environment

  • Strong work ethic and demonstrated ability to deliver assignments on time

  • Ability to travel as required (up to 40%)
About Our Organization

GRAIL, Inc. is developing paradigm-changing clinical assays for early cancer detection, based on unique biological insights from high-intensity sequencing analysis of circulating cell-free nucleic acids. We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to dramatically reduce the global burden of cancer.

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