M. Patel

About M. Patel

Productive, analytical physician with 20+ years’ extensive experience in phase I, II, and in clinical trial administration, management, pharmacovigilance and medical writing. • Strong medical therapeutic knowledge in various disease and management in collaborating with pharmaceutical industries & Academic centers. • Proficiency in poster presentation and participated in writing publication process. • Expert knowledge of GCP, Medical case review, Protocol Design, Enrollment Strategies, Clinical Trial Reports, Investigator Brochure, Data Management, SAE reconciliation, EDC (Oracle, Medidata Rave and Red Cap), electronic trial master file system (Trial interactive) Safety Database and Microsoft Office. • Strong knowledge of FDA 21 Code of Federal Regulations parts 11, 50, 54, 56, 312 and 314. • Strong knowledge on ICH Guidelines with emphasis on E1-E2 Clinical Safety, E6 Good Clinical Practice and E7-E11 Clinical Trials. • Medical Monitoring, Medical writing as well as project management skills • Excellent knowledge of EUMDR guideline and medical writing experience for medical device product lines including literature reviews, clinical evaluation plans (CEPs) and reports (CERs), post-market clinical follow-up evaluation reports (PMCFERs), a summary of safety and clinical performance (SSCPs), the clinical development plan (CDP). • Proficiency in MS Office: Word, PowerPoint, Excel, Access, and MS Project. Strong written and verbal communication skills. • Dedicated individual reputation for consistently going beyond what is required. • Networking and entrepreneurial spirit compliments to core strengths such as self-motivated, trustworthiness, team player with integrity, willingness to succeed, and ability to influence with attention to detail, including strong computer, analytical, written, and interpersonal skills. • Strong knowledge of MedDRA, WHO Drug Dictionary and coding practices. Thorough understanding of adverse event reporting and safety databases. Good understanding of the quality and confidentiality of patient data and process involved in processing the data to make it presentable as per regulatory requirements. Familiarity with J-Review application and use.

Experience

1. Medical Monitor

   argenx

   Oct 2024 — Present

   As Medical Monitor (MM) duties includes as follows:• Performed medical review Adverse Events (AEs) to identify appropriate follow-up requests and to assess expectedness, seriousness and causality. Ensure appropriate content of safety narratives. Write analysis of similar events in neurology therapeutic area.• Conducted aggregate review of safety and other clinical trial listings to ensure consistent reporting, medical logic, and appropriate coding.• Provided therapeutic, protocol, and safety reporting training to internal teams at start-up and to sites at investigator meetings.• Conducted medical review of clinical study reports and safety updates.• Performed real-time review of alert safety labs, ECGs, and other diagnostics• Involved in deviations management• Involved in signal detection activities for post marketing projects• Involved in risk-based management activities (risk-based monitoring)• Attended Investigator and sponsor meetings.• Provided medical consultation to sponsors and project team members for clinical trial program development and other activities, including business development through marketing application• Provided medical review of post-approval individual case safety reports (ICSRs) for SAEs, AEs, and product quality complaints, including causality assessments and root cause analyses.• Handled subject inclusion/exclusion queries and subject management issues requiring medical judgement.• Served as Quality Assurance specialist for TMF for medical monitoring documents• Prepared The Data and Safety Monitoring Board (DSMB) slides and presented in front of advisory board. Address recommendation and clarifications request from advisory board member.• Served/played important part in CRO selection and management.• Expertise blinded and unblinded case review, applying clinical judgment and standardized criteria to deliver high-quality, reproducible adjudication outcomes

Education

• M.P. SHAH MEDICAL COLLEGE, JAMNAGAR

  Doctor of Medicine - MD

• M.P. SHAH MEDICAL COLLEGE, JAMNAGAR

  Bachelor of Medicine, Bachelor of Surgery - MBBS, Medicine

• B. J. Medical College

  Master's degree, Anesthesiology Residency Program