Anuja Bakkam

Background

About Anuja Bakkam

Highly attentive and detail-oriented professional with over 3 years of progressive experience in progressive experience in clinical research, project management, data analysis, regulatory compliance, clinical data management & operations, research & development and clinical trial across Pharmaceutical domain. I’ve always been a great problem solver achieving extraordinary results and performing great work with my current employer. My background includes planning, developing and leading process improvements and managing projects to develop new and improve existing systems and procedures processes, & initiatives to drive continuous quality efforts and improvements. During the course of experience, I have honed my skills in clinical site evaluation, monitoring multiple site locations, initiating studies, instructing site personnel on the proper conduct of studies/trials, ensuring accuracy of data collected and terminating studies in accordance with ICH-GCP guidelines & company SOPs, while ensuring integrity & study data. My expertise lies in presenting trial protocols, designing data collection forms, liaising with trial coordinators & principal investigators, monitoring the trail throughout the project, verifying data, setting up trial sets, preparing visit reports, closing down trial sites and creating technical trial reports for submission. I have continually demonstrated a vast knowledge of managing vital quality assurance initiatives, compliance concerns, audits, and operational processes & procedures within corporate guidelines. Well versed in inspecting products, running tests, ensuring products meet standards, adhering to safety standards, developing new testing methods, and maintaining equipment. Additionally, I have good exposure in exceptional relationship-building skills, leveraging superior interpersonal abilities, ensuring maximum corporate compliance with regulations. Specialties: Project Management | Quality Management | Clinical Studies | Research and Development | Data Analysis | Clinical Data Management & Operations | Regulatory Compliance