Clinical Trial Manager / Sr. Clinical Trial Manager

Karius

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 05/31/2021
  • Website: kariusdx.com
  • Company Address: 975 Island Drive, Suite 101, Redwood City, CA, 94065

About Karius

Karius provides genomic insights for infectious diseases to enable clinicians to make critical treatment decisions.

Job Description

Karius is a venture-backed life science startup focused on transforming the way infectious diseases are diagnosed.  Combining Next-Generation Sequencing and proprietary data analysis, we can identify over 1,000 pathogens from a single blood sample with typical turnaround time in one business day. By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, with a future vision of accelerating clinical trials, discovering new microbes, and reducing patient suffering worldwide. 

Position Summary
Karius is on a mission to help clinicians do more for their patients by bringing the genomic revolution to infectious disease diagnosis. We are looking for an experienced self-motivated, critical thinker that can work independently within a high performing clinical operations team. In this role, the Clinical Trial Manager is responsible for the management of a portfolio of projects and studies across different clinical study programs that applies Karius’ novel diagnostic technology within specific clinical indication(s). 

Why Should You Join Us?
Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale. 

Reports to:  Director, Clinical Operations 

Location:  Redwood City, CA 

Primary Responsibilities
•  Drives all aspects of clinical trial management and process from site selection, qualification, initiation, planning, execution, and closure of clinical study sites while maintaining compliance with ICH and GCP guidelines.
•  Acts as the operational focal point and coordinates the clinical trial efforts for both Karius sponsored and/or collaborative studies.
•  Responsible for the project scope, timeline, budget, contracts, communication, risk assessment for clinical studies, as assigned.
•  Manage vendors, such as CRO and central laboratory vendors.
•  Participates in selection of CROs/vendors.
•  Assists with the development of relevant documents including protocols, informed consents, case report forms, monitoring plans, other study plans, and clinical study reports, as requested.
•  Responsible for Institutional Review Board (IRB) preparations and submissions.
•  Assists with development of Standard Operating Procedures and best practices, as requested.
•  Monitors and controls the execution of the clinical study and coordinates clinical team.
•  Reviews and/or creates study documents and tools for the execution of the study and ensure compliance with protocol and overall clinical objectives.
•  Ensures adequate clinical staff training and compliance, including providing Clinical Research Associates with project-specific training and regular meetings with them.
•  Collaborates with other relevant groups to identify qualified clinical study sites, and vendors required in the execution of planned clinical studies.
•  Coordinates review of data listings in preparation of clinical study reports.
•  Build strong relationships with sites and internal teams.
•  Responsible for study forecasting, metrics and reporting tools.
•  Mentor junior CRAs, as needed. 

What’s Fun About the Job?
Karius is operating at the edge of what is now known to be possible in infectious disease diagnostics. With that, comes a wave of new and incredible challenges and opportunities. To deliver on that value, you will be tapping into some of the most advanced technologies, architecting and innovating where the current solutions simply don't suffice. You will get to see how much your work really matters.

Travel: Travel required 25-35%. International travel may be required in future. 

Physical Requirements
Work is generally performed in an office. Subject to extended periods of sitting and/or standing, computer work and moderate noise levels. 

Position Requirements
•  Bachelor’s Degree in scientific or health related field or equivalent years of experience.
•  5-7+ years Clinical Research and development experience required, including relevant Clinical Trial Management experience.
•  Experience with project, vendor, contract, and clinical research staff management.
•  Advanced knowledge of Good Clinical Practice (GCP) and current knowledge of FDA regulations of clinical trial regulation is expected.
•  Experience with Institutional Review Board (IRB) preparations and submission is required.
•  Experience writing, reviewing and editing clinical protocols and study reports.
•  Must demonstrate ability to scale programs.
•  Experience with CRO or vendor management.
•  Valid driver’s license.  

Personal Qualifications
•  Must be an excellent communicator and able to summarize key findings, risks in a succinct manner.
•  Ability to anticipate and identify potential roadblocks to meeting goals and identify corrective actions.
•  Display a high level of commitment and professionalism and is truly passionate about being on the cutting edge of science and generating the appropriate clinical evidence.
•  Excellent written and verbal communication skills, including ability to effectively present information and respond to questions from project teams, external vendors, KOLs, and customers.
•  Ability to work independently, collaboratively and manage deadlines.
•  Exemplary project management skills with the ability to build schedules and mitigate against timeline delays. 

At Karius, we value a diverse and inclusive workplace and provide equal employment opportunity for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company.  All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at [email protected] and we will accommodate qualified individuals with disabilities.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.