Melissa J.
Clinical Operations Consultant
About
*PMP-Certified pharmaceutical industry profession with over 20 years of experience which includes over 10 years of Clinical Project Management experience and over 5 years of Clinical Monitoring experience *Participated in and provided direction and leadership throughout Phase I-IV of clinical research in many therapeutic areas *Experienced Clinical Project Management experience within small niche Sponsor/CRO companies as well as large Sponsor/CRO companies *A successful leader able to drive a cross-functional clinical team ensuring robust project and risk management planning as well as delivering studies on time and within budget *Consistently relied upon to prepare quality deliverables to adapt quickly to shifting priorities, and to provide insight and suggest solutions to strategic challenges *Experienced with both functional and line management Therapeutic Experience: *Oncology *Rare Disease *Vaccines *CNS * Autoimmune * Endocrinology *Respiratory *Infectious Disease
United States
Washington DC-Baltimore Area
Pharmaceuticals
Institutional Review Board (IRB), Vendor Management, Clinical Protocols, Research Skills, Presentations, Written Communication, Program Implementation, Teamwork, Multi-national Experience, Critical Thinking, Outsourcing, Timelines, Regulatory Guidelines, Microsoft Excel, Problem Solving, Site Selections, Skill Development, Microsoft Office, Supplier Evaluation, Data Integrity
Experience

Clinical Operations Consultant
Apis Cerana Clinical, LLC
Washington DC-Baltimore Area

Clincal Study Manager
Astellas Pharma
Greater Chicago Area
Melissa J.'s Contact Information
Phone
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