Senior Clinical Research Scientist: Lead Device Trials

Abbott; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott seeks a qualified clinical affairs professional to organize and conduct performance evaluations for new products and improvements. You will serve as the clinical resource on product development teams, collaborating with R&D, Regulatory Affairs, QA and Marketing to identify user needs and market segments.

You will develop clinical performance evaluation plans, conduct literature reviews via PubMed, and provide input for regulatory submissions, ensuring medical accuracy in documents for FDA

Qualifications

• Bachelor’s Degree in Biological Science or similar; Master’sDegree preferred.
• Extensive knowledge of clinical study design, evaluation and regulatory submissions.
• Experience with literature reviews and data interpretation.

Responsibilities

• Provide clinical knowledge in protocol development and trial design.
• Contribute to analysis and interpretation of study results for submissions.
• Prepare scientifically sound, medically accurate documents for regulatory agencies like FDA.
• Use PubMed and references to support decision-making and regulatory plans.
• Review and input on CRF development with biostatistics and data management.
• Assess risks and perform health risk assessments for device studies.
• Interact with physicians, engineers and QA to align clinical evaluation plans.
• Support post-market clinical evaluations of new designs or enhancements.

Skills

Clinical expertise

Literature review

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s Degree in Biological Science or similar

Master’s Degree preferred

Tools

PubMed

Reference management software

Job description

Abbott seeks a qualified clinical affairs professional to organize and conduct performance evaluations for new products and improvements. You will serve as the clinical resource on product development teams, collaborating with R&D, Regulatory Affairs, QA and Marketing to identify user needs and market segments.

You will develop clinical performance evaluation plans, conduct literature reviews via PubMed, and provide input for regulatory submissions, ensuring medical accuracy in documents for FDA