Now’s our time to inspire the future of healthcare together.
Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 60,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.
Sr Manager, Clinical Operations
Responsible for design, planning, execution, and interpretation of clinical trials/research and the data collection activities. Works closely with counterparts in Data Management and Biostatistics in development of clinical trial database and data interpretation.
Approves clinical plans, protocols, data collection systems, and final clinical trial reports.
Monitors adherence to protocols, standard operating procedures and resolves study completion.
Maintains good collaborations with leading scientists in the field in order to monitor priorities related to products under development.
Responsible for representation of Clinical Operations on Product Development core teams, particularly on complex projects that involve both platform/system and assay development.
Lead the budgeting and planning necessary to support clinical trials during product development.
Approve both clinical and analytical sections for regulatory submissions.
Represents Clinical Operations on cross-functional teams as well as liaison to Data Management or Pre-Market Biostatistics.
Collaborate with Regulatory Affairs and FDA or other regulatory and global (e.g. WHO, CDC) authorities regarding clinical research in support of product registration.
Provides leadership and mentorship to teams of Clinical Research Associates.
Education and Experience (in years):
• Bachelor’s degree in a scientific discipline with 6+ years relevant experience OR MS with 4+ years of relevant experience OR PhD with 2+ years relevant experience within medical device (IVD preferred), biotech, or pharmaceutical
• 4+ years of people management experience
Knowledge and skills:
• Have a proven track record in acquiring FDA clearance/approval of In Vitro Diagnostic (IVD) products, preferably in immunodiagnostics.
• Must have demonstrated accomplishment in obtaining diagnostic product clearances/approvals through U.S. FDA, and successful audits/inspections of clinical evaluation sites.
• Knowledge of applicable clinical research/study regulations (FDA, GCP, ISO, IVDR).
• Must be able to assess product feasibility and early development data and it’s relation to predicting outcome of clinical study.
• Ensures budgets, schedules, and performance requirements are met on core teams.
• Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
• Experience as a member of product development core teams preferred.
• Travel requirements up to 20% in non-pandemic times
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date.
(Note: Accommodations may be requested for certain medical or religious reasons)
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.
If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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