Alexis Lee Email & Phone Number

Creedmoor, Nc, Us

Collaborate with executive leadership, change management experts, and other stakeholders to develop visual communication strategies and presentation tactics to inspire and inform internal audiences. Lead end-to-end production of colleague testimonial videos, motion graphic explainer videos, and informational presentation material in support of transformation initiatives. Collect and analyze data to assess stakeholder needs, pain points, and opportunities for visual communication development.Key Achievements:▪Developed and managed visual communication strategy for several study startup systems and a vendor management process optimization effort, creating deliverables to support organizational readiness at each stage of rollout process.▪Led a campaign focused on the awareness and prevention of Changes in Scope (CIS). Designed the campaign brand and distributed monthly newsletters company wide. Created promotional testimonial videos to explain the importance of overconsumption prevention. This campaign resulted in $550 million in signed CIS within 6 months and provided employees with best practices to prevent CIS in the initial stages of the trial.▪Assisted with the Clinical Trial Management System (CTMS) Migration team with communication strategy and creation of visuals to help employees understand their role in migration, resulting in increased team participation by 80% and enabling the team to meet migration deadlines.▪Created a company presence for the SAS Cloud Migration Project. Developed the logo, SharePoint, Q&A Forum, Teams channel, and SAS Cloud User Guide on a short timeline with minimal direction and executive-level stakeholders. This helped the team direct their analyst to resources that would help them complete their migration to SAS cloud on time.▪Developed a system for measuring impact of Creative Projects, resulting in 90% efficiency and proper tracking of KPIs and project reach.

Conduct initial protocol feasibility assessment and initial country selection analysis. Deliver protocol-specific country recommendations via data-driven insights. Lead local team to deliver pre-qualified sites including but not limited to providing initial training on study protocol, launching Feasibility Questionnaires, and resolving resourcing and performance issues. Act as Project Leader on stand-alone feasibility studies, liaising with Sponsors and managing project assessment and initiation, resource procurement and planning, project implementation, milestone planning and tracking, and project oversight.Key Achievements:▪ Led a team of Global Site Feasibility Liaisons, providing training and mentorship to drive 20% improvement in efficiency.▪ Developed and maintained strong relationships with principal investigators, sponsors and clinical site staff resulting in a20% improvement in trial satisfaction.▪ Increased enrollment by 15% on an inherited trial, with complicated sponsor requirements and specific inclusion criteria.▪ Implemented process improvements to reduce feasibility timelines by 15%.▪ Successfully led feasibility for 40 global trials with site counts ranging from 50- 600.▪ Became the SME and TA lead for Women’s Health Trials (contraception, breast, ovarian, menopause, infertility, urogyn),acting as Feasibility lead for most of the women’s health trials awarded to our team.

Morrisville, North Carolina, United States

• Liaise with Clinical Monitoring, Site Start Up, Regulatory Affairs, other interdepartmental team members and sponsors to enable a rapid clinical trial start-up.• Creates/Coordinate the development of the feasibility questionnaire for a study. Reviews the protocol, seeks expertise from applicable supporting functions (CTM, Medical, PM, Contracts, Regulatory, etc.), and finalizes draft for sponsor review, as required. Works with PM to obtain client approval of the study specific feasibility questionnaire, as needed.• May support Site Feasibility Lead/Manager in working with client to obtain/agree to study specific Confidential Disclosure Agreement (CDAs) Template for a study. • Distribute Confidential Disclosure Agreements (CDAs) and feasibility questionnaire to sites and follow up with sites accordingly to ascertain interest and to meet study timelines.• May review and negotiate the CDAs according to country specific requirements, seeking legal/management review when required.• Documents/escalates study challenges and communicates updates to Project Manager and SSU Lead/Management.• Maintains up to date and accurate tracking on the Site Feasibility status for each site in applicable system(s) for the study. • Liaise with team members to understand budgets for the studies they are working on and are accountable for maintaining project activities within documented scope and budget .• Identifies out of scope activities to Site Feasibility Management, Project Manager and team and assures that such activities do not begin until the appropriate authorization is provided .• Responsible for transitioning sites from Site Feasibility to SSU representative.

United States

• Update and maintain PI Database contact entries.• Update and Maintain proprietary Infostart tracking Database• Run reports and conduct searches for PI experience in the PI Database.• Correspond with potential investigators and sites regarding study opportunities.• Supports PI Database project lead on database improvement and data cleaning projects.• Assist ISSC Leads and ISSC Managers with reports as needed.• Metric reporting as needed to support various requests • Lead Daily Team Meetings and assign tasks based on the team's bandwidth.• Conduct all activities according to appropriate IQVIA and/or sponsor SOPs. • Support Associate with feasibility packet development e.g. UAT for eFQ.• Document study challenges and effectively communicate those to the Feasibility Analysts, Site Feasibility Associate, Lead and/or SSU Manager.• Schedule and conduct Site kick off meetings and educate the study on Site Identification processes and develop a timeline for completion of the site list.

Raleigh-Durham, North Carolina Area

Produce attractive and effective designs for all media, including print, website, ecommerce, email, social media and packaging. Liaise effectively with clients and other team membersCapture & edit photos for projects across various departments as neededManage studio props - inventory, ordering, and loggingManage marketing materials, including production and reorders

Schedule and screen eligible patients for research studies• Conduct and Document follow ups and protocol specific testing and interviews• Travel to various sites for study implementation• Evaluate each site for study feasibility and monitor progress• Train others to run the study and collect data to upload into EDC• Troubleshoot data issues and provide support to team• Work collectively with my team to meet goals and monitor data points

▪ Register and schedule all new patients into the All scripts system.▪ Input clinical documentation on behalf of the physician or medical director▪ Documentation of patients encounters, medication lists, medical treatment, problem lists, prescriptions and referrals in Allscripts EMR and Allscripts PM.▪ Scan and Index Documentation of patient insurance and demographic information.▪ Medical record documentation. Accurately code the primary/secondary diagnoses▪ ICD-10-CM and coding conventions.▪ Follow physicians written instructions for scheduling of appointments for ancillary tests.

Rtp, Nc

▪ Performing QA checks on Plasma test results According to cGMP guidelines.▪ Processing Plasma Shipments for licensed and unlicensed plasma centers while following SOP's.▪ Contacting Plasma centers and requesting documents for review.▪ Updating Plasma shipment information via Company specific Database▪ Indexing plasma batches by Vendor Number and Plasma Center.

Rtp,Nc

▪ Responsible for receiving CRFs sent in from clinical research sites and processing according to SOPs in a timely manner.▪ Contacting Vendors as needed to obtain required documentation, and also to resolve outstanding DCF's▪ Routine Q.C. Testing /Audits of test results and all projects according to cGMP▪ guidelines▪ Assist with user acceptance testing for study specific and core CDM applications▪ Track CRFs and DCFs▪ Performs edit checks and Validations▪ Assist in updates for Data Entry Specifications

Raleigh-Durham, North Carolina Area

▪ Responsible for clinical data review, edit check review and data clarifications on complex projects▪ Responsible for query generation/resolution, coding of terms, and reconciliation activities to support the delivery of clinical data according to client quality Review of Case Report Forms▪ Prepared forms for data entry as determined by review guidelines and standard department procedures.▪ Document, resolve and integrate data queries.▪ Completed all relevant audit trail materials, Assisted in performing database audit(s) with project database manager.▪ ∙ Communicated/coordinate with team to ensure clean database.▪ ∙ Interacted with clients as necessary.▪ ∙ Monitored project progress/maintain accurate project documentation.▪ ∙ Executed database management/perform data maintenance and validation.▪ ∙ Performed Initial Review of Queries.▪ Performed Quality Control review of the database against the working copies of the CRFs to ensure that all data had been entered accurately.