This is an individual contributor role.
Are you looking to be a part of something exceptional? If working for Siemens Healthineers in the Point of Care Business Area piques your interest, then this opportunity is for you! We are looking for an experienced Clinical Affairs (i.e. clinical operations) professional to join our enthusiastic and collaborative team.
The selected individual will:
- Design, initiate, and coordinate in vitro diagnostic studies to collect data to support regulatory submissions and for use in future product development
- Take responsibility of ensuring the execution of clinical studies with the goal of adhering to target timelines, budget and quality
- Report to Director, Clinical Affairs, Quality, Point of Care Business Area
- Managing clinical studies independently, which may include protocol development including risk rationales and study design, CRF development, investigational product supply management, budget/contract negotiation and regulatory document management
- Conducting and/or assisting clinical teammates with on-site visits, including qualifications through close-outs; training clinical sites on implementation and conduct of study protocols
- Monitoring conduct/compliance of clinical studies as related to GCP, SOPs, and regulatory requirements, utilizing knowledge of the diagnostic area sufficient to perform source data verification; occasional handling of biological samples may be required, based upon project need
- Assisting clinical sites with IRB submission/documentation, as needed
- Assisting in the preparation of the clinical portion of Pre-Subs, 510ks and other regulatory submissions
- Anticipating and identifying issues; implementing solutions, proposing corrective actions in areas relevant to the role
- Cross-functionally assisting other Quality colleagues, Regulatory Affairs and Quality Systems, as workload permits to support efforts in these areas
Required Knowledge/Skills, Education, and Experience
- CCRA certification with ACRP or SoCRA
- Demonstration of 5-8 years of professional know-how and experience in Clinical Affairs; evidence of successful performance of responsibilities presented above
- Experience with in vitro diagnostics and/or medical device industry
- Experience conducting cardiac-focused clinical studies
- Demonstration of strong writing skills in all job responsibilities (e.g. protocols, monitoring reports, correspondence, clinical study reports, etc.)
- Demonstration of effective oral communication skills with clinical sites, and internal/external personnel from various departments/levels
- Ability and willingness to travel, depending upon project need (occasionally up to 40% domestically; 10-20% internationally)
Preferred Knowledge/Skills, Education, and Experience
- Medical Technologist or similar (MT/MLT) highly preferred
- Experience with Pre-Subs and 510k submissions
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Mid-level Professional
Job Type: Full-time
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