This position supports the execution of internal device processes associated with clinical trials. Ensure compliance to global processes and regulations. Partner closely with clinical study teams, site coordinators, Finance, Supply Chain, Quality, and Compliance groups to develop and lead the execution of the device process.
• Provide guidance on timely and accurate shipment initiation, investigational device inventory, and returns according to regulatory and company guidelines
• Continuous process improvement of efficiency and accuracy of processes and procedures.
• Provide support of device accountability process within electronic database for internal team members (e.g., clinical specialist and field monitors)
• Develop basic timeline assessment and/or work with senior level team members on complex timeline assessment (e.g., transition to new device system, system enhancements, etc.) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines
• Assist management in making changes in SOPs, Work Instructions and IFUs in Ignite system to support all Clinical projects.
• Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables
• Other incidental duties may include but not limited to Sunshine Act Reporting, Clinicaltrials.gov registration, Contracts, and Payments
Education and Experience:
Bachelor's Degree required, 3 years of experience, previous clinical trial management experience Required
• Proven expertise in Microsoft Office Suite, including Excel, JDE, electronic database (e.g., Salesforce) required
• Good written and verbal communication skills and interpersonal relationship skills
• Demonstrated problem-solving and critical thinking skills
• Moderate understanding and knowledge of fundamental principles, theories, and concepts relevant to clinical trial management
• Moderate understanding and knowledge of clinical device accountability
• Moderate problem-solving, organizational, analytical and critical thinking skills
• Moderate understanding of regulatory requirements (e.g., CFR, GCP) and documents
• Moderate knowledge in Microsoft Office Suite, including Excel, JDE, electronic database required
• Good written and verbal communications skills
• Moderate problem-solving skills
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.