Susan McFarland

WORK HISTORY

EDUCATION

SKILLS

ABOUT SUSAN MCFARLAND

Highly competent, dedicated Clinical Trial Manager with more than 28 years of experience in clinical research (Phase I-IV); including over twenty five in clinical leadership and other positions (Regulatory, Clinical Monitoring, and Project Management). Provided successful, customer-focused leadership of Global multi-functional area teams, provided portfolio-level management of 6 clinical trials to ensure consistency and quality across the portfolio, routinely conducts several clinical trials simultaneously and provided direct line management of thirteen CRAs. Experienced in client support of FDA audit, managing audit responses, identifying clinical trial risks, contingency planning, optimizing patient enrollment, organizing rapid study start-up, facilitating meetings, managing vendors, executing database lock and close-out, training project team members and site staff, and managing performance in order to successfully achieve project milestones and timelines.Participated and prepared for a sponsor audit of CRO and study with zero noted findings; Participated in SOP review and improvement initiative focused on Clinical Operations process improvement; Achieved FPI within 2 months of receiving final protocol on 2 studies simultaneously; Successfully assisted and participated in sponsor FDA study audit with only minor findings and no 483 issued; COPD study fully enrolled 500 patients 2 months ahead of planned end of enrollment; Subject matter expert for sponsor audit responses and submitted several responses that had no comments returned from the sponsor auditor prior to finalization; provided input into several focus groups developed to drive process improvement; locked 2 databases and completed an interim lock on a third with approximately 500 sites on time in 5 weeks; Acted as the “Lead” Lead CRA on a team of 5 Lead CRAs; Consistently receive positive client feedback both from solicited surveys and also unsolicited where study team had sponsor CEO write a letter of praise to functional managerSignificant experience in Allergy/Pulmonology (Allergic Rhinitis/Asthma, COPD), Cardiology (Atrial Fib, CHF, DVT/PE), Dermatology (Psoriasis), Endocrinology (Type II Diabetes, Hypercholesterolemia), Gynecology (FSAD), Infectious Disease (HIV), Neurology (Multiple Sclerosis, Parkinson’s), Oncology (Breast, Colorectal, Hairy Cell Leukemia, Head and Neck, Multiple Myeloma, Non-Hodgkin\'s Lymphoma, Ovarian, Prostate, KRAS G12D Solid Tumor), and Rheumatology / Immunology (Rheumatoid Arthritis, Lupus)