• 15+ years’ experience in the Clinical Research Industry, concentrated in Clinical Data Management (CDM), CDM Project Management, Line Management, and Operational Oversight• 10+ years’ experience as a DM Project Manager• Supervise up to 10 direct and indirect reports in a variably matrixed environment• Experience coaching and mentoring reports in planning, startup, conduct and closeout activities with an eye toward timelines, risk management and financial health of their projects.• Provide operational oversight to several sponsor portfolios• Experience in phases 1, 2 and 3 from both CRO and Sponsor perspectives• Therapeutic area experience includes Oncology, Cardiovascular Disease, Neurology, and Infectious Disease• Other various activities include mentoring/training, SME work, process improvement initiatives, and support of business development• Working knowledge of medical and clinical terminology; clinical research, data management, and project management procedures; FDA, ICH, GCP regulations and guidelines • Strong time management and organizational skills; Able to multi-task and accommodate changing business needs • Responsible, detail oriented, professional, and ambitious • Strong work ethic and commitment to high performance
Listed skills include Edc, Clinical Data Management, Oracle Clinical, Data Management, and 23 others.