Associate Director Of Clinical Affairs@ MCRA
Stacy, Minnesota, United States
Patrice Lerum
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St. Cloud State University
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FlashIntel GPTPatrice Lerum is a highly experienced professional with 24 years of work experience in the clinical research device industry. She has a strong background in clinical trials, development, FDA regulations, and GCP. Patrice is known for her ability to create a trusting and high-performance culture that allows her to visualize and implement new business concepts within a regulated environment. She has a proven track record of implementing new business concepts within a regulated environment and has expertise in planning and implementing European Union Medical Device Regulations. Patrice has held various positions in reputable companies such as MCRA, Covidien, and Medtronic.
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About
Professional Profile I am a natural leader with the versatility of both project and people management over the span of 22 years in the clinical research device industry. I am one who strives for results by creating a trusting, high-performance culture that includes transparent communication and a light-hearted working environment. Moreover, I have the capability to visualize and implement new business concepts within a regulated environment.Summary of Experience• Knowledgeable with FDA regulations (pre-clinical & clinical research)• Knowledgeable with FDA (21 CFR 812) Good Clinical Practices (GCP)• Knowledgeable with ISO 14155:2020 guidance• Planning & readiness of European Union Medical Device Regulations (EU MDR)• Adherence to standard operating procedures (SOPs)• Project & timeline management• Budget management & annual operating planning (AOP)• Strategic planning within clinical research operations• Relationship building & influence management in a matrix organization• Adaptability in a changing work environment• Led team building exercises & encourage inclusion of diversity of thought• Training, Development & Mentoring others• Hiring top talent & performance management
...See MoreWork Experience
Associate Director Of Clinical Affairs
Medical Equipment Manufacturing
Patrice Lerum's Professional Milestones
- Veterinary Technician | Laboratory Animal Technician (1999-11-01~2005-11-01): Accurately diagnosing and treating animals in laboratory settings, ensuring optimal performance within the laboratory environment.
- Clinical Study Manager (2019-06-01~): Overseeing the successful launch of groundbreaking drugs, driving research and innovation in the field of medicine.
Education
Master Of Science,
Masters,
Applied Clinical Research (acr)
2016-2019Skill
Clinical Trials
Clinical Development
Fda
Gcp
Clinical Research
Medical Devices
Glp
Data Management
Ctms
Cross Functional Team Leadership
Sop
Quality System
Cardiology
Healthcare
Regulatory Affairs
Clinical Monitoring
Training
Protocol
Capa
Certification
Colleagues
Michael Anselmo
Vice President Of Reimbursement | Health Economics | Market Access
John Doucet, PhD
vice president regulatory affairs - neuromodulation and evolving technologies at mcra llc
Tim Marjenin
vice president head of neurology regulatory affairs at mcra llc
Charles Schneider
Vice President
David W. Lown
President
Other Named Patrice Lerum
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Patrice Lerum works for MCRA
Patrice Lerum's role in MCRA is Associate Director Of Clinical Affairs
Patrice Lerum works in the industry of Medical Equipment Manufacturing
Patrice Lerum's colleagues are Michael Anselmo,John Doucet, PhD,Tim Marjenin
Patrice Lerum's latest job experience is Associate Director Of Clinical Affairs at MCRA
Patrice Lerum's latest education in St. Cloud State University
