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Senior Project/Account Manager, Clinical Operations

Koneksa Health is an early stage technology company transforming the way we measure what matters in health.  

Our experienced team is focused on using new technologies to improve clinical research and drug development. We help leading life sciences companies and research hospitals remotely capture real-world data from patients. Our projects deploy digital health technologies such as FDA approved activity trackers, wearable vital sign monitors, and other emerging monitoring devices that capture data outside the clinical and laboratory setting. We are developing digital biomarkers that help our customers make faster decisions, often using smaller studies, with technologies that enhance the experience of the patients who participate. We’re on a constant quest improve the tools and endpoints that are used to get the right new therapies to patients who need them.

We are actively seeking to hire an account manager with 4+ years of relevant experience to help our clients design and execute their clinical studies. This successful candidate will be supporting protocol design and development, preparation for ethical approvals, site training, deployment of software and devices, and ongoing execution all the way through study close out.

The account manager will work with alongside our current technology and account management team members to ensure that our client’s needs are met.  This role reports into the VP of Business Operations.  

Responsibilities

  • Serve as main point-of-contact with client study team, research site coordinators, and other vendors to support all aspects of client study execution, including:
    • Study requirement gathering and translation into device or ePRO selection
    • Incorporation of technology requirements into protocol design and informed consent
    • Train study site and coordinators
    • Inventory management / logistics
    • Facilitate and/or attend study team meetings (Site initiation visits, weekly meetings, etc.)
    • Study close out activities
  • Support software testing with both technology and data science teams before platform is turned over to customer/coordinators
  • Manage vendor relationships for device/sensor vendors supporting each study
  • Work with our technology team to ensure study configurations meet client and protocol requirements
  • Help troubleshoot any issues which may arise with study participants or coordinators using the platform, for everything ranging from issues with devices/sensors to software problems
  • Test / use all devices and technologies (hardware and software)
     

Required Experience

  • Project management, planning and support of interventional clinical studies
  • Contributing to the development or approval of study protocols and supporting documents such as informed consent forms, 
  • Knowledge of the US and / or international regulations governing human subject research for investigational new drugs

Business/Technology Qualifications

  • Strong presentation and communication skills
  • Understanding of the drug development process (IND through Post-markt)
  • Issue management and stakeholder navigation
  • Significant technology knowledge and curiosity; understanding of web and mobile applications

Bonus

  • Experience with activity trackers / wearable devices / sensors
  • Experience with Clinical Trial Management Systems / Electronic Data Capture
  • Experience with a software/technology company

Benefits

  • Competitive salary
  • 100% covered employee healthcare
  • Weekly team lunches
  • Healthy office snacks
     
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