Alexandra Almazan Email and Phone Number

• Review essential regulatory documents for accuracy and completeness as required by FDA regulations, Good Clinical Practices (GCP), sponsor’s requirements, and SOPso Contribute to two multinational cardiology medical device studies consisting of the two main studies and four sub-studies at 65 sites and their corresponding satellite siteso Assigned as a main contact with the in-house CRA for 14 of the 65 sites under the two multinational studies which includes email and phone calls with site coordinators, investigators, field CRAs and field clinical specialistso Focus on study start up and maintenance• Conduct periodic in house review of associated documentation and participate in internal and FDA audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulationso Lead of an internal eTMF audit of the 65 sites participating in one of multinational cardiology medical device studieso As lead, managed a team of 13, created templates for use in the audit, managed timelines for completion, conducted bimonthly progress report meetings for the team and management• Develop and conduct training on GCP, regulatory documentation, and electronic Trial Master File (eTMF) for staff and sites• Identify trends through the use of metrics and resolve issues in collaboration with field clinical research associates, principal investigators and support staff, study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations, and recommend and develop basic process improvements.• Experience with clinical trial management system (CTMS) and Veeva Vault eTMF

• Design and implement preclinical pharmacology studies that support the development ofdrugs for the treatment of retinal diseases such as age related macular edema and thedevelopment of a sustained release drug delivery device for the treatment of glaucoma• Assist clinical department with organization of wet lab sessions for investigator meetings duringimplementation of Phase 1 clinical trial• Develop imaging processes and analytics for use in preclinical studies and clinical trial• Write study protocols and reports that have been incorporated and cited in IND submissions• Monitor multiple preclinical studies at a contract lab• Knowledge of anatomy, physiology, and drug distribution in the human and research animaleye• Continued contribution to the development of drug delivery system for treatment of glaucomao Present data to task force, core and sub teams, and department meetingso Processed and analyzed pre-clinical and clinical data that influenced clinical trial study protocolo Continue to support program with designing and implementing pre-clinical studies to answer questions that arise from on-going clinical trials• Sub-team member for ocular antiseptic program• Work in a team/matrix environment with collaboration with teams within basic research, non-clinical and clinical development which include but not limited to image analytics, implementation of in-vivo tolerability and efficacy studies, due diligence assessment of a novel drug and device treatments for glaucoma, training of colleagues on dosing and device placement, creation of animal model for assessment of minimally invasive glaucoma stent (MIGS)• Oversee team lab operations• Technical abilities:o Working with common clinical ophthalmic instrumentation such as OCT (anterior and posterior), fundus imaging, slit lamp examinations, specular microscopyo Proficient in intravenous, intravitreal, intracameral, and suprachoroidal injections

• Sought out opportunity for practical experience in clinical trial management using knowledge from Clinical Trials certificate program• Shadowed Senior GCTM colleague on start-up and progression of dermatology studyo Aided in troubleshooting enrollment issues by reviewing study protocol and making suggestions for improvemento Sit in on weekly clinical trial team meetingso Assisted with tracking completed CTAs in GDD budget template• Completed photo reconciliation from multiple studies during close out process• Tracked incoming data from ongoing neurotoxin study