Ahmad Shaheen
Clinical Research Associate @IQVIA
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WORK HISTORY
Clinical Research Associate @IQVIA
CA
Responsibilities: • Conducting site assessment and audit/inspection readiness. • Ensuring ethical conduct of research, e.g. medical, aspects of study. Contributes to discussions with health authorities, Ethics Committees, investigators, opinion leaders, internal and external clients. • Providing interpretation and consultation to project teams on regulations, guidelines, compliance status, policies and procedures. • Providing consultation to functional leads in interpretation of audit observations and formulation of corrective action plans. • Providing therapeutic training relevant to specific study to the project team. Attends and or presents at investigator, internal and external project team meetings. • Conducting data review, assessment and monitoring for protocol deviations and serious breaches and setting CAPA measures.
EDUCATION
Society For Clinical Research Association
CCRP, Clinical Research
Academy for Applied Pharmaceutical Sciences, Toronto, Canada
Post Graduate Dpiloma in Clinical Research
University of Dhaka
MSc in Pharmaceutical Science, Pharmacy
Queen's University
Infection Prevention and Control
Universiti Sains Malaysia
M.Sc in Clinical Pharmacy, Pharmacy
University of Dhaka
BSc.(Pharm), Pharmacy
ABOUT AHMAD SHAHEEN
Diligent and meticulous Certified Clinical Research professional with extensive experience in clinical trials, monitoring and documenting the quality, safety and effectiveness of pharmaceutical drugs. In depth knowledge of planning, organizing and managing clinical trials, overseeing clinical documentation, patient recruitment, patient care, regulatory compliance and Good Clinical Practice. Special expertise in CVS, CNS, Endocrine, Dermatology, Infectious Disease and Gastrointestinal therapeutic areas. Articulate communicator with a demonstrated ability to establish rapport, effectively liaising with medical professionals, researchers, administrators and patients. CORE KNOWLEDGE AREAS Clinical Research Methodologies Conduct of Phase Clinical Trails Good Clinical Practice Familiar with ICH Guidelines Reviewing study documentation for protocol and regulatory requirements Creating Standard Operating Procedures Reviewing Informed Consent Forms TPD, FDA Regulatory Requirements Clinical Documentation & Study Summaries Familiar with COSTAR Therapeutic Area - CVS, CNS, Endocrine,Dermatology and Gastrointestinal. Specialties: Clinical Research Data Management and Quality Control Medical Writing, Clinical Trail Phase
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