Mario Gutierrez
Associate Director of Research Operations, Johnson & Johnson MedTech
- Role
- Associate Director of Research Operations, Johnson & Johnson Medtech at Johnson & Johnson MedTech
- Location
- Cincinnati, OH, US
- LinkedIn followers
- 500 followers
About Mario Gutierrez
Mario is an Associate Director of Research Operations at Johnson & Johnson MedTech with 30 + years of healthcare research experience in the medical device and pharmaceutical industry. Throughout his career at J&J, Mario has held several positions with local and global responsibilities including trial design and execution, protocol development, IRB requirements, monitoring, good clinical practice (GCP) training, SOP development, safety management/reporting, regulatory submission, compliance/audit readiness, scientific publication management, copy review, evidence generation planning, and contract research organization management.Specialties: Clinical Research Administration, Research Operations, Audit Readiness, Compliance, Clinical Safety Surveillance, Bariatric and Metabolic Surgery, Metabolic diseases, Diabetes research, Laparoscopic surgery, Health Economics and Market Access, Real-World Evidence.
Experience
Associate Director of Research Operations, Johnson & Johnson Medtech
Feb 2019 — Present · Cincinnati, OH, US
Work in close collaboration with the global health economics & outcomes research (HEOR) J&J community and its leadership to ensure excellence in Real-World Evidence (RWE) research and ensure the highest standards in execution strategies, analytics, and dissemination. A critical position in the Centre of Excellence responsible for evidence generation and dissemination procedures. Work in close collaboration across Clinical R&D, Medical Affairs, Clinical Research, Healthcare Compliance, Privacy, Analytics, Regulatory, HCC, Finance, Legal, and Corporate Epidemiology. Key player in matrix team leadership for effective project management, execution, compliance, and risk mitigation. Lead cross-functional teams. Lead process improvements, development/updating of Policies, SOPs, and work instructions. Serve as dependable subject matter expert in research related processes and compliance including collaborative studies on innovative technologies (e.g, digital surgery solutions). Monitor compliance with standard processes and polices. Lead the development of a global research project register in MedTech and Manage a Research Operations team.
Education
Santa Barbara Business College
Certificate of Medical Assisting, Medical Assisting
1995 — 1997
The George Washington University
Master of Science (MS), Clinical Research Administration
2004 — 2007
Universidad de Guadalajara
Bachelor of Science (B.S.), Biology, Medical
1984 — 1989
Skills
- Ideation
- Self Assurance
- Medical Writing
- Maximizer
- Data Management
- Analytical Abilities
- Ich-Gcp
- Diabetes Research
- Edc
- Protocol Development
- Therapeutic Areas
- Ctms
- Adverse Event Reporting
- Irb
- CRO
- Commitment to Excellence
- Literature Reviews
- Regulatory Requirements
- Safety Management
- Ind
- Metabolic Diseases
- Clinical Development
- Medical Research
- Organizational Leadership
- Manuscript Development
- 510 K
- Clinical
- Gcp
- Process Safety
- Bariatric Surgery
- Scientific Writing
- Pma
- Clinical Trials
- Energetic
- Sop
- Fda
- Command
- Clinical Data Management
- Forward Thinking
- Writing for Publication
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