Aashutosh B.
Clinical Project Manager @Fdamap - Cro And Regulatory Expertise
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WORK HISTORY
Clinical Project Manager @Fdamap - Cro And Regulatory Expertise
Oversee end-to-end management of multiple Phase clinical trials ensuring 100% adherence to GCP, FDA, and ICH regulatory standards. Design and build electronic data capture (EDC) systems, serving as primary Database Administrator for clinical trial data management across 25+ active sites. Architect and implement Case Report Form (CRF) designs aligned with protocol requirements, reducing data queries by 35% through optimized design strategies. Lead clinical site selection, qualification, and contract negotiation processes for multi-site trials spanning USA and India, achieving 95% site activation rate. Deliver comprehensive EDC training programs to internal teams, clinical sites, and investigators, resulting in 40% faster site startup timelines. Conduct Source Data Verification (SDV) activities and quality oversight, maintaining data integrity and protocol compliance across all study sites. Manage geographically distributed global teams with remote workers across multiple time zones, providing weekly project status reports and risk assessments to sponsors. Collaborate with biostatistics teams to prepare Annual Reports and regulatory submissions, ensuring data accuracy and completeness. Partner with Regulatory Specialists to maintain compliant Trial Master Files (TMF) and essential documentation per FDA and ICH requirements. Reduced data discrepancies by 30% through implementation of real-time EDC monitoring and proactive communication strategies.
EDUCATION
Birla Institute of Technology and Science, Pilani
Bachelor of Pharmacy
Delhi Public School, Faridabad
High School Diploma
Birla Institute of Technology and Science, Pilani
Bachelor's degree, Pharmaceutics and Drug Design
SKILLS
ABOUT AASHUTOSH B.
With over 5 years of experience in clinical trial management, I am a Clinical Project Manager and EDC System Admin at FDAMAP, a leading provider of clinical research services and solutions. I manage multiple remote clinical trials for various sponsors in the US, collaborating with a global team of remote workers, clinical sites, and statistical and regulatory specialists. I ensure compliance with FDA regulations, GCP guidelines, and SOPs, and I apply my skills in CAPA, CRA, CRF design, EDC building, database administration, and source data verification.As part of my role, I also organize and set up training events, create new courses, coordinate with subject matter experts, and create profiles of customers and match them with product offerings. I leverage my skills in communication, market research, marketing, and business relationship management to deliver quality services and solutions to the clients and sponsors. I am passionate about enhancing my knowledge and expertise in the clinical research field, and I live by the motto - Teamwork makes Dreamwork!
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