- Develops and/or reviews departmental operating procedures.
- Develops study protocols for executing experiments, evaluation, and documentation of results.
- Follows standard and complex procedures in executing studies, evaluation, and documentation of results.
- Participates in the development of clinical strategy for product development.
- Designs, executes, and monitors Abbott-sponsored external clinical studies, including PMA and outcome studies.
- Identifies and qualifies external clinical sites.
- Develops and maintains operating procedures.
- Participates in clinical strategy development to support product development and market introduction.
- Participates in cross-functional product development activities, including risk management.
- Completes clinical studies successfully and on time to support product development goals and product introduction timelines.
Requirements
- Bachelors Degree (± 16 years) In a related field and/or an equivalent combination of education and work experience.
- Minimum 8 years in conducting clinical studies or related laboratory skills.
- Experience in medical device related studies is desirable.
- Knowledge of regulations governing medical devices is desirable.
- Experience conducting medical device clinical trials preferred (TAVR in particular).
- Investigational Device Exemption (IDE) trial experience.
- Physician management.
- Safety management desirable.
- Experience working with external clinical research committees (i.e. screening committees, DSMB, CEC).
Core Competencies
Demonstrates expertise in developing and executing clinical study protocols, managing external clinical sites, and ensuring compliance with medical device regulations. Proven ability to collaborate in cross-functional product development and successfully complete clinical studies on time to meet product introduction goals.
Highest-signal resume keywords
- Clinical Study Management
- Medical Device Clinical Trials
- Investigational Device Exemption (IDE) Experience
- Cross-Functional Collaboration
- Regulatory Compliance Knowledge
Hard Skills
- Clinical Study Protocol Development
- Clinical Evaluation
- Documentation of Results
- Risk Management
- External Clinical Site Qualification
- PMA Study Design
- Outcome Study Execution
- Laboratory Skills
- Safety Management
- Physician Management
Certifications & Qualifications
- Bachelor's Degree in Related Field
Industry Keywords
- Medical Device Regulations
- Clinical Strategy Development
- Clinical Research Committees
- TAVR Studies
- External Clinical Studies
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Senior Clinical Scientist Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
