We're looking for a Study Start-Up Specialist, working in the Biotechnology/Medical Devices industry in South San Francisco, California, United States.
Updates knowledge on related regulatory requirements, ensures adherence and compliance with local regulations and internal procedures.
Executes all start-up activities prior to site activation on assigned studies, according to company standards and aligns with study/project requirements and timelines.
Prepares country level Informed Consent Form (ICF) and obtains ethics committees and local regulatory authorities approval.
Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country.
Maintains and analyzes study start-up data (metrics) on assigned studies, ensures optimal efficiency to reduce start-up timelines and identifies opportunities for continuous improvement.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years’ experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
University Degree or equivalent, preferably in a medical/science-related field
Previous line management experience/supervision of staff is preferred
Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP)
We're offering Competitive Compensation and Benefits. This position may present an opportunity to go permanent.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.