We have an opportunity with a small medical device company in the neurovascular space.  Solid leadership, no drama and the opportunity to help this company grow.  This role will be focusing on the clinical data and would be responsible for overseeing clinical activities related to clinical studies and performing/managing the daily operations associated with the data of those studies, ensuring clinical trials are conducted in accordance with International Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and all applicable local and national laws.

5+ years’ experience with data management plan, safety management plan and user instructions.

Responsibilities include:

  • Assist in designing, writing, and maintaining effective clinical study protocols and other documents associated with the Clinical Investigational Plan.
  • Assist in report development and maintenance of case report forms, worksheets and other study data collection aids.
  • Participate in and drive the electronic data capture (EDC) system set up, user acceptance testing, charge order controls, and necessary EDC updates for the duration of the clinical trial.
  • Conduct training and in-services at study sites or CRO/partners or via web conference for the clinical trial EDC and any other applicable EDC system(s).
  • Maintain EDC/applicable EDC system access.
  • Oversee routine data cleaning and trending activities according to the monitoring plan, data management plan, data and safety monitoring plan, and any other applicable data and safety monitoring plans.
  • Ensure monitors are prepared for monitoring visits by monitoring data quality in a times manner and forwarding potential issues to the site monitor.
  • Serve as contact for clinical study sites to assist in issues with EDC and/or other applicable systems along with other sponsor personnel/CRO personnel.
  • Ensure investigational device accountability while monitoring expiration dates, device quantities, and any device issues/problem entered into the EDC.
  • Drive data entry and cleanliness for annual reports, safety reports and study summaries for FDA/CA submissions and site EC/IRB submissions, as required.
  • Monitor clinical study safety including serious adverse events collection and notifications, interact with clinical team for awareness, source document collection, etc. Assist in all necessary safety reporting as required by site, the EC/IRB, and local and federal regulatory requirements.
  • Assist in managing vendors providing services for the clinical study.
  • Assist CRAs to generate payment requests for sites and quarterly accruals, ensure study budget and payment tracking systems are up to date and accurate.
  • Assist with the continued development of Clinical Department including writing SOP’s, guidance documents, work instructions and other procedures as needed.