Najmul Hasan Mohammed BPharm, MPharm, AdvCert(PM)

Najmul Hasan Mohammed is a highly experienced Clinical Trial Supply Manager based in Madhapur, Hyderabad, India. With over two decades of experience in the field, including 17 years of global exposure in Clinical Trials, he has honed his skills from various roles, ranging from Research Associate to Clinical Supply Manager. His expertise extends to Interactive Response Technology (IRT) development, SAP ERP utilization, regulatory compliance, and project leadership.

Throughout his career, Najmul has consistently demonstrated a deep understanding of clinical trial protocols and their amendments. He has been instrumental in managing the distribution of clinical supplies, acting as a crucial business partner within the Clinical Trial Team. His dynamic approach involves adapting distribution strategies and IRT parameters to ensure timely supply availability while optimizing distribution costs. Additionally, he plays a pivotal role in providing accurate demand forecasts to the Drug Supply Management Supply Chain team.

Najmul is no stranger to collaborating with cross-functional teams to navigate country submission and approval timelines, including IND-IMPD amendment, all while developing an optimal supply strategy. Furthermore, he maintains responsibility for consolidating, maintaining, and tracking clinical trial budgets, ensuring efficient resource allocation for overall Clinical Supply external costs.

During his tenure at George Clinical India Pvt Ltd, Najmul assumed the role of Associate Project Manager. In this capacity, he led project management activities, ensuring the development, conduct, and completion of research projects aligned with allocated timelines and quality standards. He provided clear guidance to project teams, maintaining strong relationships with external customers, investigators, vendors, and internal project teams. His responsibilities also included coordinating feasibility planning, site selection, and staffing level calculations, ensuring the timely and qualitative execution of monitoring activities, all while adhering to patient safety and regulatory compliance.

As a Senior Clinical Research Associate at the George Institute for Global Health, Najmul provided mentorship to team members, taking the lead in project oversight and site management responsibilities. He played a critical role in site selection, initiation, monitoring, and close-outs, and was involved in minimizing QA audit observations to ensure regulatory compliance. His ability to efficiently plan and execute monitoring activities significantly contributed to effective site management.

Najmul's career journey also included roles as a Clinical Research Associate and Research Associate, where he reviewed clinical study documents, conducted site qualification visits, initiated visits, and managed site monitoring and close-out visits. He actively participated in regulatory/ethics submissions, organized investigators' meetings, and maintained regulatory documents and Trial Master Files up-to-date, ensuring smooth audits and inspections.

Beyond his clinical research expertise, Najmul's educational background is equally impressive. He holds an Advanced Certificate in Project Management from Catalyst Clinical Services Pvt. Ltd. He completed his Master's Degree in Pharmacology at Annamalai University and a Bachelor's Degree in B.Pharmacy at Jawaharlal Nehru Technological University. He further expanded his knowledge with an industry diploma in Contract Research and Clinical Trials from the Bioinformatics Institute of India.

Fluent in English, Arabic, Hindi, Urdu, and with a working knowledge of Telugu, Najmul Hasan Mohammed brings a diverse skill set and extensive experience to the realm of Clinical Trial Supply Management. His commitment to quality and regulatory compliance underscores his ability to excel in complex clinical research environments.

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