Clinical Operations Manager

Organization
NAVICAN
Job Location
San Diego, CA 92121
Job Description

NAVICAN is seeking a Clinical Operations Manager with a background in clinical research, oncology and genomics as a key team member for our scientific and clinical team.  This individual will help contribute to the execution and analysis of prospective clinical research studies supporting Navican’s current and future product offerings.  This is a great opportunity for a motivated team player looking for a challenging role where they can apply the experience of best practices learned, have influence in the development of systems, and apply their talent real-time for results.

 

The successful candidate must be a high energy, analytical, hard-working team player with an entrepreneurial spirit, who knows and can apply best practice frameworks, processes and methods while being hands-on and highly ethical.

Primary Responsibilities and Essential Duties

  • Works with the VP of Clinical and Scientific Affairs to build a clinical operations development plan.  Initiates and leads daily management of prospective clinical studies, including:  responsibility for vendor oversight, development of study operational plans, completion of study start up activities and ongoing maintenance of studies through completion. Works closely with Clinical Project Manager to track study progress.  Interfaces with CRAs for site specific initiation, training and monitoring. 
  • Prepares clinical study documents, including, but not limited to:  case report forms, informed consent documents, study protocols and amendments.  Acts as primary point of contact for clinical operations, including ethics committee to lead submission, review and follow through for approval of protocols and consents.     
  • Coordinates with extended scientific team to aggregate study data for analysis. 
  • Innovates with internal staff and external collaborators to expand the scope of Navican’s clinical translational research studies. 
  • Works with Clinical and Scientific team on publication plans supporting clinical research studies.   
  • Contribute to new product ideas and product development. 
Requirements

Education and Experience Required

  • Advanced degree in the biomedical sciences (Ph.D. with postdoctoral experience or relevant M.S. degree)
  • Preferably, 5 years of work experience in biotechnology, cancer genetics or genomics.
  • Minimum of 3 years of clinical trial research experience.  Strong understanding of functional area responsibilities associated with the clinical research process. 
  • Knowledge of regulatory requirements for clinical trial management.
  • Experience translating research findings into clinically relevant and actionable information.
  • Excellent verbal and written communication skills, in addition to excellent organizational skills.
  • Creative and capable problem solver. 
  • 20% travel required
  • Position based in San Diego

 

NAVICAN is an EOE/AA employer and offers competitive salary and benefits package.

How to Apply
About Our Organization

About NAVICAN

We’re driven by an impatience to make more precision therapy options available to more cancer patients. If you have a passion to help people, a desire to grow, and you’re excellent at what you do, join us at NAVICAN to make a positive impact on the world.

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