Andrea Scicli, Phd Email & Phone Number

San Jose, CA, US

LEAP is a private exclusive network for members of the #LeapAcademy Program: executive leaders, entrepreneurs, and high achievers from around the world who inspire and drive growth and impact on themselves, their work and their communities.

San Francisco Bay Area

Results-driven clinical trial professional with 23 years' experience with Class II and Class III medical devices. Experienced in cross-functional and industry expert collaboration, clinical operations, strategic planning, and medical writing including abstracts, publications, presentations, and regulatory submissions. Services include (but not limited.

San Jose, California, United States

Schmahl Science Workshops provides hands-on science workshops to schools that do not have the resources to include science as a regular part of their instructional program.

Palo Alto, California, United States

-Scientific writing: analyzing, interpreting, and compiling data on hypertension studies for abstracts, presentations, and publications.-Collaborated in developing and executing 3 advisory boards for new indications, used in deciding future investments.-Created and maintained an internal scientific affairs website to disseminate data and support training.

Fremont, CA

-Researched and wrote scientific content for clinical study reports, regulatory body post-approval study reports, meta-analyses, FDA submissions, publications, and presentations.-Screening and summarizing literature for regulatory body submissions

Fremont, California

-Directed the review, funding approval, and contract execution of Investigator-Initiated study proposals.-Developed process improvements for streamlined and transparent research grant approvals.

San Jose, CA

-Managed international investigational and post-marketing regulatory submissions, and full-cycle clinical study activities (start-up, monitoring, and close-out) for a clinical trial on spinal tumor ablation and a post-approval study on vertebral compression fractures.

San Jose, CA

Fremont, California, United States

-Managed 2 international investigational clinical trials in macular degeneration.-Authored study protocols, informed consents, investigator brochures, annual reports and partnered in developing submissions to regulatory bodies in the USA, Austria, Germany, UK, Israel, Peru, and Brazil.

Santa Clara, California, United States

-Analyzed, interpreted, and compiled clinical trial data for abstracts and presentations for conferences. -Project-managed writing of regulatory reports submitted to the FDA. -Strategized with the Executive Committee on the presentation of clinical data and clinical projects

Fremont, California, United States

-Led start-up initiatives for a Post Market Registry, overseeing the development of protocols, informed consents, and case report forms and established site selection criteria and ranking process-Authored clinical risk/benefit analysis, project plans, market strategy, product specifications, and risk management documents

Santa Rosa, California, United States

Prepared regulatory documents including Protocol, Informed Consent, Instructions for Use, Report of Prior Investigations, Case Report Forms, Investigator Agreements for 2 Investigational Device Exemption (IDE), and Pre-Market Approval (PMA) submissions-Coordinated the development and start-up of a multi-center clinical study including organizing and.

Phd, Neuroscience

Dissertation topic: “Neural Basis of Contextual Fear Conditioning”

Bachelor Of Science - Bs, Biopsychology

Bs, Biopsychology