Home   -   Contact Us  

Job Category:Clinical Development

Who We Are

Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
 
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!


Job Summary:

  • Manage the day-to-day activities necessary for the successful completion of clinical programs according to the clinical study protocol, DNS Standard Operating Procedures, ICH Guidelines and GCP.
  • Oversight of CROs, vendors and contract personnel.
  • May have some site monitoring or co-monitoring responsibility

          Responsibilities include:

  • All aspects of designated clinical study operations with accountability for meeting timelines, budgets and quality standards.
  • Anticipate project requirements and institute appropriate actions to ensure timelines and project goals are met.
  • Oversight of designated activities outsourced to CROs, external consultants, central and specialist labs and other vendors
  • Provide status reports and act as primary contact for management regarding project activity.
  • Manage the development of clinical documents, as required.
  • Review, develop and implement all operational and project plan(s) for assigned studies.
  • Serve as point of contact for internal departments and external vendors
  • Develop the monitoring plan and ensure appropriate quality and timely monitoring of clinical sites.
  • Review trip reports and other aspects of site monitoring including, performance metrics and quality. Identify, troubleshoot and resolve issues pertaining to site monitoring for in-house and CRO monitored studies.
  • Oversee study specific tasks such as Investigator identification, recruitment, collection of Investigator regulatory documents and site activation.
  • Manage clinical follow-up of quality assurance audit reports.
  • Organize and conduct investigators’ meetings.
  • Manage individual and team performance standards.       Identify training, development and recognition needs of project team.
  • Conduct pre-study, initiation, routine monitoring and closeout visits of study sites, when necessary.
  • Perform other duties as assigned by management.

          Travel Required:

  • Available for extensive travel (~50%) including overnight stays.
  • Ability to drive and have a valid driver’s license.


Qualifications/Requirements:

  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology
  • Thorough knowledge of ICH Guidelines, GCP and the clinical trial process.
  • Insight of study budget process including:
    • Vendor and Investigator agreements and contracts.
    • CRO budgets, invoicing and payments
    • Site budgets and payment administration
  • Understanding of data management, statistical programming and regulatory affairs sufficient to perform project management responsibilities.
  • 5-7 years+ of relevant pharmaceutical industry experience including demonstrated skills and competency in monitoring and clinical project management tasks.
  • Ability or potential to manage clinical projects with minimum supervision.
  • Ability to work within a project team and lead or potential to lead a project team.
  • Ability to train / supervise and mentor junior staff.
  • Good planning and organizational skills.
  • Excellent verbal and written communication skills.
  • Ability to represent DNS in a professional manner.
  • Good computer skills with good working knowledge of a range of computer packages.

 


Benefits:

DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan. Click here to learn more.


Dart NeuroScience is an Equal Opportunity Employer/Minorities/Women/Disability/Veterans.

EEO is the Law | EEO Policy