I am a well-seasoned and highly accomplished professional with a sizeable tenure. I have spent my experience accumulating knowledge and achieving set goals through delivering my best at every step of the way to provide optimal results. I firmly believe in establishing and maintaining the key partnerships and relationships that prove productive and allow for better performance.I am an established professional with an analytical mindset. I have well over 15 years of experience, along with an extremely successful and proven track record at handling multiple roles and massive projects without any delays. I am highly collaborative, and I can perform exceptionally well in teams as well as by myself. I thrive in fast-paced business environments and cherish a chance to self-manage things through my innate problem-solving skills. I possess verifiable leadership, interpersonal, and communication skills that allow me to put across my side of things with a crisp point to peers and colleagues and the management. I am a remarkably successful mentor to my peers and colleagues, owing to my exceptional people's skills, and have always given them the nudge in the right direction to go the extra mile. I am positively confident in my capability to deliver impeccable results through my dedication and ability to handle multiple roles, functions, and activities deftly under high-pressure environments.Areas of Expertise:• Global and local Clinical Trial Management under MDR & FDA regulations in the Medical Device industry/ Medical Hospital.• Clinical Research Contracts, Timelines & Budgets, and Regulatory Documents (including Competent Authority & Ethics Committee) engagement.• Trial Site Feasibility, Qualification & Selection, Vendor Selection & Management, TMF Development & Management, and Resource Management. • ICH GCP, HIPAA, FDA, MDR, and IRB Policies and Guidelines • Data Quality and Process Improvement Management • Human Resource and Research Personnel Management • Local and Global Clinical/Biomedical Research Management in Aerospace • Experience with NASA flight operations processes and project development• Biopharmaceutical and Medical Device Industries and Academia• Microsoft Office Suite
Listed skills include Hplc, Elisa, Sds Page, Purification, and 14 others.