Business Unit: Laboratory Diagnostics
Requisition Number: 235027
Primary Location: United States-New York-Tarrytown
Other Locations: United States-Delaware-Newark
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthineers
Provides study management and operations of clinical studies conducted worldwide, and assures successful completion consistent with applicable regulations, guidelines and policies.
Develops clinical strategy for products in development.
Provides support and regulatory guidance.
Provides responses during regulatory body review of product submissions
Oversees and manages clinical project personnel and/or consultants.
Independently handles multiple clinical study assignments.
Expected 15% travel
Location: Tarrytown, NY or Newark, De
B.S. degree in a healthcare/scientific discipline or equivalent education with a minimum of five (5) years’ experience managing clinical activities in a medical device or in vitro diagnostic field. Masters Degree desirable. Thorough knowledge of GCP, ICH guidelines and other US and international clinical regulatory requirements. Demonstrated experience in managing clinical trials, including risk assessment and contingency planning. Monitoring experience required. Excellent communication, project and people management, organizational, problem solving, conflict resolution, leadership and team building skills. Data management experience desirable.
• Manages activities performed by direct reports, consultants and/or Contract Research Organizations.
• Proficient ability to manage people. Training plan and yearly performance assessment experience required
• Participates on product development teams as clinical representative.
• Ensures appropriate resources and priorities are maintained for the assigned projects.
Manages and report on budget.
Responsible to ensure new direct reports are trained
• Monitors or ensures adequate oversight of study is conducted.
• Creates, improves and implements departmental procedures and clinical study documents.
• Communicates and presents study results and program issues to project team and other key internal stakeholders (development, marketing, operations, etc.).
• Manages clinical development budget within stated financial goals.
• Monitors compliance with all FDA and applicable regulations concerning clinical activities.
• Oversees the internal and external audit programs for clinical studies.
• Evaluates clinical data/information and writes reports, abstracts and papers as required.
• Managing clinical trials experience for at least 3-5 years
• Proficient in GCP, ICH guidelines and other US and international clinical regulatory requirements
• Experience in IVD is preferred