Vi Pham Email & Phone Number

United States

• Serve as the primary clinical project coordinator for 15+ clinical sites across the United States in a PHASE III, randomized study for treatment-resistant depression • Lead and host 30+ meetings every month with clinical sites to ensure appropriate patient screening activity, adherence to study protocol and assessments, and positive patient interaction• Write 30+ technical trial reports every month that details challenges, successes, and patient activity for management review • Develop recruitment initiatives and strategies to increase screening potential at each clinical site for study enrollment• Liase with 10+ vendors and third-party contractors, and collaborate on a day-to-day basis to facilitate study-related processes• Review, name, and file essential documents for TMF • Monitor and review data submission in EDC for each clinical site

Fremont, Ca

• Manage a self-sufficient team of 15+ individuals with a focus to build a solid foundation of collaboration, responsibility, and teamwork• Train new employees on business operations, in addition, important professional skillsets to be better prepared for future endeavors, including public speaking, customer service, accountability, quality, efficiency, and a strong work ethic• Familiar with proper HR related practices to ensure compliance with federal, state, and city regulations• Oversee all operations of the business with an eye to maximize time and accuracy• Strong customer-relationship development skills to better improve customer service and ensure that all expectations are not only met, but exceeded

Fremont, California, United States

• Collaborate with CRO and corresponding contract labs to uphold study quality and data integrity of oncology Phase I clinical trial with an enrollment of 74 patients.• Responsible for the maintenance of study databases, including entry of patients’ data in EDC for completion.• Write, review, and oversee the implementation of investigator’s brochure (IB), study protocol, informed consent form (ICF), laboratory and pharmacy manuals, data transfer agreements (DTA), and other study forms. • Manage biospecimen collection from clinical sites by checking shipment status to contract labs, scheduling batch analyses, and confirming proper storage conditions.• Assess testing protocols and data analysis for drug substance/drug product manufacturing and stability testing, following ICH guidelines.• Orchestrate meetings between CRO and Sponsor to facilitate fluid communication, present concise project updates, and produce succinct meeting minutes. • Supervise the development of junior project associates.• Manage adequate stock of drug inventory, medical kits, and other supplies at clinical sites to streamline patient enrollment.• Prepare and deliver study-related updates, dashboards, and reports to management, vendors/partners, etc. for oral presentation.

San Jose, Ca

• Developed related substances method using HPLC for aNDA submission• Wrote validation protocol for an impurity method and completed the entire protocol in a contract lab• Serve as project manager for a high-priority project by contacting outside personnel, organizing internal and external meetings, and setting up timelines

San Jose, Ca

• Proficient with HPLC and U-HPLC (Agilent and Chemstation) for analysis of small molecules• Accurately analyze chromatographic peaks with working knowledge of HPLC conditions and parameters • Develop methods for assays and impurity assays for molecules using GC and HPLC• Effectively prepare cadaver skin by stripping the stratum corneum for use in skin flux experiments• Leader of preparation and analysis of multiple-day skin flux experiments • Troubleshoot LC and U-HPLC instruments without guidance• Successfully led a team of five members through GLP manufacturing of 1000+ patches for submission into nonclinical trials• Determine purity and decomposition of various small molecules through forced degradation studies• Review and write reports for R&D use as well as for prospective clients• Correctly adhere to all SOPs for GLP and GMP manufacturing

Mountain View, Ca

• Leader of Genentech project, testing compound stability and purity • Effectively collaborated with team on producing a novel drug-aerosol molecule• Knowledgeable and experienced with high performance liquid chromatography (HPLC), thermogravimetric analysis (TGA), and differential scanning calorimetry (DSC)• Determined emitted dose, particle size, and purity of aersol compounds• Maintained a well-recorded notebook of all laboratory experiments

Davis, Ca

• Improved student’s overall grades in class and on final exams• Created personalized lesson plans to meet individual student’s needs• Tutored in geometry, trigonometry, algebra 1&2, chemistry, biology, and SAT Prep• Assigned and graded homework assignments for every lesson

Davis, Ca

• Collaborated with fellow interns to effectively manage student-run clinic• Actively assisted doctors with pap smears and liver screenings • Accurately translated Vietnamese to both doctors and patients • Measured vitals for patients in a timely manner to meet heavy flow of appointments• Carefully followed clinic protocol when handling patient’s blood and urine samples