Mohsin Shaikh
Lead Clinical Data Manager @Axiom Real-Time Metrics
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WORK HISTORY
Lead Clinical Data Manager @Axiom Real-Time Metrics
CA
Effective management of all data and reports (management reports and clinical research data reports) based on project protocol from Phase I-IV Clinical Trials (as per SOP and GCP)Designing, Implementation, Validation and testing of eCRF, annotated CRF, Data Export Specifications, SAS Data listings and reports into AXIOM FUSION eCLINICAL SUITEDevelop data integrity plans and edit check module for data review and presentationMedical Coding as per MedDRA and WHO Standard Guidelines (Medical Coding Conventions) for Adverse Events, Serious Adverse Events, Concomitant Medication and Medical History during clinical research trial along with data reporting for PharmacovigilanceResponsibility for all aspects of data management for each study, including issue and resolution ofqueries wherever applicableFollow up on eCRF and query completion with Clinical Trial sites as well as SponsorRemote site support, and constant communications with Clinical Research Study Coordinators, Site Monitors as well as sponsors from a data management perspectiveOngoing support for the management of the project and associated ancillary initiatives (e.g. database lock and coding, etc)Assist, where applicable, with the maintenance of the Axiom Fusion eClinical Suite application in conjunction with the Project ManagerResponsibilities throughout lifecycle of a Clinical Research projectClose, ongoing collaboration with members of project team to ensure project runs smoothly and efficiently and that overall strategic objectives are realizedLeading, training and supervising a group of Clinical Data Managers/ Data Management Associates as well as Data management interns on regular bases
EDUCATION
MS University of Baroda
Bachelor of Medicine, Bachelor of Surgery (M.B.B.S.) Foreign Medical Graduate, Medical Clinical Sciences/Graduate Medical Studies
MS University of Baroda
Doctor of Medicine (MD), Epidemiology
Project Management Institute, Canada
Associate's Degree, Project Management
Applied Pharmaceutical Science, Toronto
Post Graduate Diploma in Clinical Research, Clinical Research
SKILLS
ABOUT MOHSIN SHAIKH
E-mail: d••••••••@gmail.comI bring over 10 years of Clinical Research Operations experience, with a very strong medical and clinical research background, including management, planning, administration, supervision and leadership. I possess excellent knowledge of GCP/ ICH E2A, E6, E8 & E9 guidelines, SOP, Protocols, FDA, Health Canada and regulatory requirements, Pharmacovigilance as well as MedDRA and WHO Coding. I have monitored, supervised, evaluated as well as delivered various clinical research projects successfully within the regulatory, budgetary and project timelines. I am highly efficient in research design, data collection and analysis using SAS, SPSS, Epi Info, Tissue Matrix and MS office software. Specialties: Clinical Research Monitoring, Supervision, Project Management, Electronic Data Capture, Medical Coding, Clinical Study Administration, Leadership & Development, Training and Mentoring, Clinical Study Implementation, Targeted Source Data Verification, Pharmacovigilance
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