Sr. Clinical Trial Manager

Shifamed

Shifamed

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Los Gatos, CA, USA

USD 140k-175k / year + Equity

Posted 6+ months ago
Position: Sr. Clinical Trial Manager, Supira Medical
Location: Los Gatos, CA
Job Id: 596
# of Openings: 0
Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical, please visit www.supiramedical.com.
ABOUT SHIFAMED
Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology
Description:
The Sr. Clinical Trial Manager (CTM) is primarily responsible for working closely with cross functional teams, vendors, sites and CROs to ensure compliance with global clinical feasibility trials. The Sr. CTM is responsible for completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates and resolves clinical study operational issues; and participates in process improvement initiatives. They will also have a positive, energetic and flexible attitude, with a reputation for being a results and delivery-oriented self-starter. This is a full time on-site position and will require reporting to our offices located in Los Gatos, CA.
Responsibilities, Skills & Hands-On Experience:
  • Ensure compliance with study protocols, clinical investigational plans, and SOP's
  • Ensure compliance to regulatory requirements, ICH GCP, FDA regulations, and IRB/EC requirements
  • Manage study start-up activities including document preparation of study materials for institutional review board (IRB/EC) approvals
  • Develop study project plans, monitoring plans, training materials, and recruitment materials
  • Manage the site selection and qualification process including contracts and site budgets
  • Conduct site qualification and site initiation visits
  • Prepare presentation materials for site visits, training, and meetings with study investigators
  • Oversee study monitoring activities in accordance with the monitoring plan
  • Conduct monitoring/co-monitoring visits, review monitoring reports and resolve any issues with sites
  • Setup and Maintain the Trial Master File (TMF) system throughout the study
  • Determine and manage clinical supplies and device accountability as required for trial conduct
  • Oversee proper collection of data in an EDC system for monitoring, study reports, and analyses
  • Participate in UAT as needed; setup and maintain a site payment process
  • Plan and manage investigator and coordinator meetings
  • Prepare, review, and distribute monthly study newsletters
  • Support activities for Clinical Event Committee and Data Safety Monitoring Board reviews, as needed
  • Develop study tracking tools for project updates and timelines
  • Prepare and present weekly project updates for the project team
  • Assist in preparing accurate and timely annual reports, safety reports and study summaries for regulatory submissions
  • Manage and train a study team of Clinical Research Associates (CRAs), field clinical monitors, core labs, consultants, CROs, and other vendors for feasibility, pivotal, and other clinical trials
Education & Work Experience:
  • BA/BS in Life Sciences or another medical-related field
  • Minimum 7 years related experience in managing global clinical trials for medical devices
  • Must have experience managing study startup, monitoring, and closeout activities
  • Must have knowledge of ISO 14155, FDA regulations (23 CFR Part 11, 50, 54, 56, 812) and ICH Good Clinical Practice
  • Data management, EDC development, Safety, and vendor management experience is preferred
  • Must have the ability to work with limited supervision
  • Travel ~10-15% as needed

Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full-time position is between $140,000 to $175,000 + equity + benefits.
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