Co-chairs clinical study teams and serves as the primary point of accountability for the design, conduct, interpretation, and reporting of clinical studies
Job Summary
Co-chairs clinical study teams and serves as the primary point of accountability for the design, conduct, interpretation, and reporting of clinical studies.
Provides clinical and scientific expertise to strategy and protocol development, ensuring efficient protocols through Enhanced Clinical Trial Design (ECTD) / Enhanced Quantitative Drug Development (EQDD).
Manages site liaison responsibilities, building relationships with site staff and ensuring understanding of protocol requirements to overcome operational barriers.
Matching Summary
Co-chairs clinical study teams and serves as the primary point of accountability for the design, conduct, interpretation, and reporting of clinical studies.
Skills & Requirements
Must-have
clinical study design and conduct
protocol development and amendments
clinical data interpretation and reporting
Good Clinical Practices (GCP) knowledge
regulatory compliance for clinical trials
Nice-to-have
collaborative team environment
proactive risk identification and mitigation
mentoring and leadership skills
stakeholder relationship management
Key Requirements
M.D., Ph.D., D.V.M., M.S., and/or PharmD or equivalent qualifications
Postgraduate training, certification or fellowship in a medical discipline or drug development is preferred
Demonstrated scientific productivity
Thorough understanding of local and international regulations
Practical experience in clinical trial strategies, methods and processes
Track record of design, oversight and interpretation of clinical studies
Previous leadership or management experience or training
Experience in conduct and execution of clinical trials