Anikait Madan
Global Study Manager @ AstraZeneca
About
Welcome to my LinkedIn profile! With a rich background in clinical research spanning various roles, I bring a comprehensive perspective to the dynamic landscape of healthcare innovation. My expertise spans across early phase development, bioavailability/bioequivalence (BA/BE) studies, and late-phase development, with a special focus on the dynamic field of Oncology. Throughout my career, I have been deeply involved in advancing therapies and treatments that make a meaningful difference in the lives of patients. At present, I proudly serve as a Global Study Manager at AstraZeneca, where I lead cross-functional teams and oversee the strategic planning and execution of global oncology trials. My role not only demands meticulous attention to detail but also requires adept problem-solving skills and a collaborative mindset to navigate the complexities of clinical research. I am always eager to connect with fellow professionals, industry experts, and individuals who share a common interest in advancing oncology research and improving patient outcomes. Let's connect and explore how we can collaborate to shape the future of healthcare together.
Canada
Vaughan
Hospital & Health Care
Program Launch, Budget Management, Patient Safety, Resource Management, Regulatory Standards, Problem Solving, Regulatory Compliance, Corrective and Preventive Action (CAPA), Clinical Research Management Systems, Clinical Operations, Biochemistry, Clinical Study Management, Biotechnology, Google Cloud Platform (GCP), Institutional Review Board (IRB), ICH, Data Privacy, Clinical Research Associates, Clinical Monitoring, Research Ethics
Experience
Global Study Manager
AstraZeneca
Mississauga, Ontario, Canada
Late Development Oncology
Clinical Research Associate
Parexel
- Conducting Qualification Visits (QV), Site Initiation Visits (SIV), Monitoring Visits (MV), Termination Visits. - Performing Source Data Verification (SDV) and Source Documentation Review (SDR) - Working with multiple systems including iMedidata RAVE, Veeva Vault, IXRS/IWRS, Data Driven Monitoring,
Clinical Research Associate
The Hospital for Sick Children
Therapeutic Areas: Haematology/Oncology, Solid Tumours New Agents and Innovative Therapies Phase 1 Oncology
Clinical Research Coordinator
BioPharma Services Inc.
Therapeutic areas: Cardiovascular, CNS-Psychiatry, GI Subject matter expertise: Bioequivalence, Bioavailability Studies, Phase-1 in healthy volunteers
Research Assistant - CRC
BioPharma Services Inc.
- Assisting CRC's in study related activities, including preparation of study specific documents, study specific delegation of responsibilities, study initiation meetings, addressing QC and QA Audit reports, data clarification in accordance with the Protocol, SOP's and GCP Guidelines - Perform detailed review of documentation created by Study Preparation Associates - Assist in preparing and maintaining the ISF - Coordinate with the Medical Writing and Data Management teams to achieve milestones for project specific timelines with respect to soft locking and hard locking data - Worked with Senior Management of Clinical Research to develop and update internal SOP's -Collaborates with the Project Management Team to host on-site and remote Monitors and Sponsor Audits and respond to any queries and findings - Assist Study Managers in training newly hired CRC's in preparing study reports, tables and general study procedures according to the SOP's
Student Research Assistant
Women's College Hospital
Toronto, Canada Area
Therapeutic Area: Chronic Pain Toronto Academic Pain Medicine Institute Involved in aspects of REB applications, SPIRIT (standard for trial protocol), Consenting, data collection and management
Rides Operator
Canada's Wonderland
Vaughan, Canada area
- Performed safety checks using the Provincial and Federal guidelines and ensuring the ride is safe to operate prior to allowing guests - Ensured guests are safely seated and explaining them safety guidelines before dispatch - Problem solve in a calm and composed manner during down-time or during emergency situations while dealing with guests and evacuations - Create a cheerful atmosphere and provide excellent customer centric service and ensure the guests truly have the best day of the year experience during their visit
Education
University of Toronto
Health and Disease
CRA School of Montreal, Canada
Dalhousie University
Anikait Madan's Contact Information
Phone
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