Senior Clinical Scientist

• 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 the product development.
• Responsible for the design, execution and monitoring of Abbott sponsored external clinical studies including PMA and outcome studies.
• Responsible for identification and qualification of external clinical sites.
• Responsible for the development and maintaining of operating procedures.
• Participates in the development of clinical strategy to support product development and market introduction.
• Participates in cross functional team activities for product development including risk management.
• Successful and timely completion of clinical studies directly impacts the ability to meet product development goals and product introduction timelines.

• 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).

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 teams to achieve product development goals and timelines.

• Clinical Study Protocol Development
• Medical Device Clinical Trials
• Investigational Device Exemption (IDE) Experience
• External Clinical Site Management
• Cross-Functional Team Collaboration

• Clinical Study Execution
• Study Evaluation
• Documentation of Results
• Risk Management
• Operating Procedure Development
• Clinical Strategy Development
• PMA Study Management
• Outcome Study Management
• Laboratory Skills
• Regulatory Knowledge

• Team Collaboration
• Communication
• Problem-Solving
• Leadership

• Medical Device Regulations
• Clinical Research Committees
• Safety Management
• TAVR Studies
• Physician Management