Thousand Oaks, California, United States
Successful Manager with over 20 years experience in the Global Clinical trial environment covering multiple disease areas and trial phases. Experienced leadership in people, project and program management. Responsible for the Global standardization and coordination of large multiple cross-functional program teams. Proven record of developing solid relationships with a number of key Pharmaceutical companies.
Successfully planned, scheduled and directly managed operational activities of up to 27 Project Managers and Project Associates to ensure accurate set-up and monitoring of clinical studies. Led global initiative across departments to create processes needed to service one of the largest preferred provider service agreements to date at Quest Diagnostics Clinical Trials. Created a workload status tool that ensured resources were adequately deployed within Project Management. Used workload tool to plan and organize team resources Led and implemented 2 Six Sigma Green Belt projects. Participated in 2 in Six Sigma Black Belt projects. Interacted daily with ancillary departments and Labs to improve operations and quickly resolve challenges.
Responsible for recruiting, hiring and training new staff within Project Management. Provided supervision, planned and coached the Clinical Studies Team. Team included Project Managers, Project Associates and Client Relations Specialists. Ensured customer satisfaction was achieved through accurate and timely study set-up by the team of Project Managers. Participated in process improvement committees and fostered continuing process awareness within the Project Management Team.
Primary contact at SmithKline Beecham for pharmaceutical companies. Initiated, planned and oversaw the day to day activities of multiple clinical trials. Directly responsible for generating central laboratory specifications and directly communicating with the client study management team, CRAs and investigators. Responsible for maintaining good working relationship with the client by conducting ongoing weekly/monthly meetings. Ensured successful delivery of each project and meeting client defined data base locks. Worked with team to ensure proper monitoring of samples and patient data. Designing required forms, working with scientific teams to ensure testing and all necessary testing codes are in place and are functional. Attended and presented relevant materials at Investigator meetings and site initiations personally or via teleconference.
Assisted in developing protocol specific manuals to satisfy the detailed requirements of sponsors and investigators. Monitored and coordinated Quest services for the study investigators. Assisted in problem resolution utilizing whatever resources necessary to support the protocol. Developed and maintained client databases to avoid delivery delays.