MOHAMMED SOHAIL AHMED

• Oversee and coordinate Phase I-IV clinical trials, ensuring compliance with GCP, ICH guidelines, and FDA regulations
• Lead the execution of a Phase III clinical trial on a novel cardiovascular drug for heart failure treatment, evaluating its efficacy and safety profile in comparison to existing therapies
• Monitor investigational sites to ensure adherence to protocols, patient safety, and data integrity throughout the study lifecycle
• Conduct site initiation, routine monitoring, and close-out visits to ensure regulatory compliance and proper documentation
• Collaborate with principal investigators, site coordinators, and healthcare professionals to optimize patient recruitment strategies and minimize dropout rates
• Ensure accurate and timely reporting of adverse events (AEs) and serious adverse events (SAEs) in accordance with MedDRA and pharmacovigilance standards
• Work closely with cross-functional teams, including data management, biostatistics, and regulatory affairs, to ensure seamless trial execution
• Contribute to protocol development, informed consent review, and ethical committee submissions to facilitate trial approvals
• Utilize CTMS, EDC, and other clinical trial technologies to streamline data collection, site management, and reporting
• Provide training and mentorship to junior clinical research associates, ensuring adherence to best practices, GCP standards, and regulatory compliance
• Assist in the preparation and submission of regulatory documents to health authorities, ensuring timely approvals for trial progression
• Conduct risk-based monitoring and implement corrective and preventive actions (CAPAs) to ensure clinical trial integrity
• Coordinate site feasibility assessments, budget negotiations, and contract management to support efficient trial execution.

Led and managed clinical research protocols, ensuring rigorous adherence to regulatory requirements and standard operating procedures (SOPs).

Spearheaded patient recruitment efforts, optimizing enrollment strategies to enhance trial efficiency and patient retention.

Conducted comprehensive data analysis and adverse event reporting using MedDRA, ensuring compliance with global pharmacovigilance standards.

Developed and standardized SOPs aligned with FDA and OHRP regulations, fostering consistency across all clinical research activities.

Directed the Pharmacy and Therapeutics Committee (PTC), driving NABH accreditation through evidence-based practice improvements.

Supervised clinical trial budgets, coordinating financial and resource allocations to ensure smooth project execution.

Provided training sessions to clinical staff on best practices in research ethics, protocol adherence, and data management.

Established and maintained strong relationships with sponsors, CROs, and regulatory authorities, facilitating smooth trial operations.

Conducted quality control checks and prepared audit-ready documentation to maintain compliance with regulatory standards.

Assisted in the development of new treatment protocols and research methodologies to enhance study outcomes.

• Coordinated and managed multiple clinical trials focused on endocrine disorders, ensuring strict adherence to study protocols and GCP standards
• Conducted protocol feasibility assessments and optimized study site selection for enhanced research efficacy
• Led data collection processes, ensuring integrity, accuracy, and timely submission of research findings
• Provided strategic input on risk assessment, patient safety monitoring, and compliance with ethical guidelines
• Collaborated with interdisciplinary teams to refine research methodologies and improve trial outcomes
• Assisted in developing research grant proposals, securing funding for key endocrinology-focused clinical trials
• Reviewed and refined study protocols to enhance efficiency and compliance with regulatory requirements
• Engaged in direct patient interactions, ensuring proper informed consent processes and protocol compliance during study participation
• Supported principal investigators in drafting manuscripts and research papers for peer-reviewed journals
• Conducted retrospective analyses of clinical trial data to identify trends and areas for improvement in patient care and study design.