Kelly Mckee Email and Phone Number

Responsible for identifying, piloting and deploying novel and innovative strategies to improve clinical trialsCenterwatch Top Innovator, Jan 2018www.herosjourneyart.comhttps://www.buzzfeed.com/elilillyandco/things-you-didnt-know-about-how-medicine-gets-approvedwww.LillyTrialGuide.comwww.PopUpStarCommunity.comhttp://myfox8.com/2017/11/21/artwork-installed-at-innovation-quarter-in-honor-of-clinical-trial-participants/

 Responsible for leading GTO’s recruitment and retention center of excellence that provides strategic input into all Merck late stage clinical trials  Oversee the patient recruitment process, providing expert solutions and guidance to clinical trial teams across Merck’s portfolio of clinical studies.  Manage team of Global Trial Optimization Specialists through vision, leadership, oversight and mentoring to provide support to clinical program and study teams  Collaborate closely with Clinical Science and Study Management Therapeutic Area Leads, Program Managers, and regional colleagues to align with senior management  Ensure that GTO provides expert analysis and recommendations to design and deploy recruitment and retention strategies and tactics to ensure that clinical trial programs are delivered on-time and within budget to meet business objectives Identify and deploy novel and innovative clinical trial recruitment and retention solutions and serves as the liaison for the department to Legal, Privacy, and Research Procurement to ensure that all strategies and tactics align with Merck’s regulations and SOPs. Ensure project management of vendors Serve as Merck’s subject matter expert for all recruitment and retention related activities to drive continuous improvement of processes, functions and deliverables  Lead and participate in various cross-functional, global work streams to improve processes, support and deliverables  Represent Merck on cross-industry collaborations and presents at international conferences (SCOPE, CTTI, CROWN, Allen Lloyds, Trial Networks/Drug Dev Summit, Partnerships with CROs, etc.)

Infectious Disease and Vaccine Therapeutic Lead for Feasibility, Site Validation and Recruitment and Retention

Responsible for the expert analysis and recommendations on clinical trial feasibility, site selection and validation, and design and deployment of recruitment and retention strategies and tactics to ensure clinical trial programs are delivered on-time and within budget to meet business objectives.Provide vision, leadership, oversight, mentoring and coaching of Global Trial Optimization Specialists in producing GTO deliverables.

Trialytics - Patient Recruitment Division of SDILead clinical development team for site selection, protocol feasibility and patient recruitment activities of Phase I-IV studies supporting major pharmaceutical and biotechnology companies across various therapeutic areas including oncology, neurology, cardiology, internal medicine and infectious disease utilizing electronic healthcare data. Accountable for coordination and delivery of all cross-departmental projects supporting clinical trials including direct-to-patient pharmacy pre-screening and recruitment.Business development responsibilities include account management of existing and future customers. Involved in all phases of the RFI, RFP and proposal process and responsible for authoring of all documents. Presentations include capabilities, bid defense, and results deliverables to clinical and procurement sponsor teams.

ACRP certified CRA responsible for the execution and reporting of Phase II and Phase III clinical cardio-thrombosis studies. Onsite monitoring of clinical studies including Pre-Study Visits, Site Initiation Visits, Routing Monitoring Visits, and Close Out Visits

Responsible for the execution and reporting of an international Phase IIIb clinical pneumonia study as a member of the Clinical Study Team including oversight of four marketing companies (clinical research units) and two laboratories (central processing and PK analysis); development and maintenance of study web site; authoring of Informed Consent template; development of Case Report Forms, CRF Review Manual and Protocol Amendment; investigator and monitors’ meeting oversight and presentations.

Responsible for managing an ongoing, national influenza surveillance program. Duties included: oversight of study budget and timelines; authoring of Protocol and Informed Consent; monitoring of 400 physician sites and 150 laboratories; supervising an Associate Project Manager and two Program Specialists; conducting twice weekly surveillance teleconferences and monthly client project meetings; issuing twice weekly, monthly and year end reports. Prepared customized investigator recruitment scripts and trained staff. Maintained and supervised changes to the database.

Responsible for the investigation and monitoring of 57 reportable infectious diseases including AIDS, Lyme Disease, Enteric Diseases, Hepatitis and West Nile Virus.Designed and implemented West Nile Virus Educational Program.Conducted a published study on disease reporting practices among physicians, hospital microbiology laboratories, commercial laboratories and community health centers.