Sr. Clinical Trial Manager
Sr. Clinical Trial Manager
Posted on :
21-06-2025
Employer Active
1 Vacancy
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Monthly Salary
$ 140000 - 175000
Vacancy
1 Vacancy
Posted on :
21-06-2025
Job Description
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 .
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
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 SOPs
- 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) 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 and level. Your position within that range will be determined by your job-related knowledge skills experience relevant education and training/certifications. In addition to those factors we also examine internal equity as well as consider current market rate and title may be assessed one level lower or higher accordingly. After you join the company your performance contributions and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $140000 to $175000 equity benefits.
Required Experience:
Manager
Employment Type
Full Time
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