Talented Management Executive with 25+ years industry experience, and success managing service delivery and implementation teams delivering global programs and projects on time and within budget. Accomplished launching and leading new departments, service offerings, and process improvement initiatives. Collaborative leadership style with exceptional ability to train and leverage talent. Result oriented with strong analytical skills, and big picture focus.
· Oversight for all aspects of service offerings, pricing, operations, and roadmap for the Medidata Clinical Cloud.
· Financial responsibilities for multi team global budgets, timelines, deliverables, and resourcing.
· Expert for complex issue management, in-depth analysis, and resolution.
· Extensive collaboration with Operational Excellence, PAO teams for internal initiatives and mentoring programs.
· Multi team management comprised of Consultants, Project Directors and Managers specializing in cross functional delivery of small to large scale global programs for all of Medidata's Clinical Cloud solutions.
· Established and grew a global business unit specializing in image upload and workflow management.
· Developed service offerings and operational process for new imaging and Televisit application.
· Established global knowledge transfer and process delivery standardization.
· Established new hire onboarding lunch and learn program including course content development.
· Performed all activities associated with project and program management.
· Manage and mentor all eClinical Solutions staff for North and South America. Responsible for all aspects of this team.
· Establish and mentor a new team of remote contract employees (Technology Project Leaders and Technical Trainers).
· Develop internal training programs to include process workflow and all collaborative material.
· Develop and own pricing, operations, roadmap, and strategic direction for EDC services.
· Pro-actively market the services of eClinical Solutions including sales presentations and bid defense meetings.
· Create and present eClinical Solutions budgets and proposals.
· Consultant and subject matter expert for EDC technology.
· Oversight and management of all finances within the eClinical Solutions team.
· Conduct site monitoring visits to include SIV, interim, and study closeout visits.
· Organization, verification, and return shipment of clinical trial supplies.
· Creation and maintenance of all required study and monitoring reports.
· Creation and oversight of multi-center prostate cancer database.
· Protocol development and IRB submission for multiple research projects.
· Partnered with clinic physicians and led all aspects of in-clinic research activities.
· Conduct training for new CRC's including installation and training on database for multiple military medical centers.
· Primary contact for patients and medical staff for the Center for Prostate Disease Research.
· Creation and oversight of all aspects related to Prostate Cancer Awareness Day.
· Draw and process laboratory specimens, order radiological procedures, conduct patient intake assessments.
· Identify and screen patients for enrollment in clinical trials.
· Management of multi-center bladder cancer study.
· Draw and process laboratory specimens, order radiological procedures, conduct patient intake assessments.
· Case report form completion, and query resolution.
· Dispense study medication.
· Protocol and annual update submissions to local IRB.
Publications
Filipp, G. & Pagos, T. (2010). EDC is Now – The Changing Role of the CRA. A. McConaghie (Ed.), The CRO Guide 2010 (pp. 15). West Sussex, UK: Pharmafocus.
Presentations
EDC is Now: Changing Role of the CRA, Mastering Clinical Trial Monitoring, Cambridge Healthtech Institute, June 2010, Cambridge, MA