Description
Essential duties & responsibilities include but not limited to the following:-
Assist in managing all aspects of clinical studies to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines -
Perform the activities of planning, implementing, monitoring and managing clinical trials -
Provide supervision and guidance, clinical trial management expertise and direction to in-house and contract CRAs and CROs -
Analyze/report safety issues, patient care issues, and study design and/or study conduct issues -
Participate in the design and development of clinical trial protocols and case report forms
Requirements:
-
BS/BA in Life Science or related discipline -
8-12 years industry experience in drug development -
Proven ability for success in leadership position, including fiscal responsibility
To find out more about Real please visit www.realstaffing.com