Farnaz Malik
Clinical Trial Coordinator @Tata Memorial Hospital
Signup · Get unlimited contacts
WORK HISTORY
Clinical Trial Coordinator @Tata Memorial Hospital
Mumbai, IN
Proficiently screening, counseling, consenting, and randomizing patients during the trial• Developing and dispensing investigational new drugs to the patients• Promptly resolving the reimbursement issues of the patients• Carrying out telephonic follow-ups of the patients• Precisely collecting and entering data of patients for trial analysis• Effectively submitting the trials to CTRI, clinicaltrials.gov, HMSC, maintaining CRFs, trial master files, and logs • Flawlessly filling SAE, CRA, violation, deviations, and submissions to the Ethics committee• Meticulously filing project submission forms, annual continuing review applications, amendment forms, project completion forms, and submissions to the Ethics committee• Coordinating with the Ethics Committee and filing trial-related documents• Correlating with the PI/EC and promptly resolving trial-related queries• Managing the shipment of samples in coordination with the courier people• Systemizing the investigations and retrospective & prospective trials in correlation with the PI team• Ensuring high-level of patient care is provided throughout the clinical research trial• Actively participating in project meetings & monthly staff meetings as and when needed
EDUCATION
University of Mumbai
Bachelor's degree
University of Mumbai
Master's degree
ABOUT FARNAZ MALIK
Quality is never an accident. It’s always the result of intelligent effort”I am a qualified Clinical Research Management professional with 3+ years of progressive experience in core clinical research operations management. As a Clinical Trial Coordinator, I\'m currently associated with Tata Memorial Hospital, Mumbai, India. A positive, self-motivated, and goal-oriented professional with a proven track record of handling various clinical research teams across high-complexity clinical studies, ensuring high-quality deliverables at all times as per client requirements.I am well versed in clinical operations and project management as per regulatory standards, including stakeholder management consisting of vendors, CSAs, regulatory authorities, clinical sites, cross-functional teams consisting of project leads, CRAs, CTAs, Data management, Data Analytics, Medical data review teams, Site management, on a global and regional level.A client-facing role having regular weekly interactions with the client on various study deliverables, understanding the delivery requirements, forming the operational plan for the same, training the study team, and executing the operational plan resulting in high-quality deliverables within the agreed timelines.I’m known for:Assisting the research team and providing support to the relevant stakeholders within the project team for assigned deliverablesPromptly resolving all technical queries and communication for various processes on the entire trial programsDeveloping all study documentation, report reviews as per annotations, guidelines, etc, and conducting CRA training and monthly site reports to discuss significant issues emerging from the trends noted during report reviewCertification:Diploma in Clinical Research, Clinical Data Management, & Pharmacovigilance” from MITCON BiopharmaI’m skilled at:Clinical Trails & Research Management, Clinical Study Management, Project Management, Project Planning, Regulatory Standards Compliance, Clinical Site Management, R&D Management, Training & Development, Requirement Gathering & Analysis, Process ImprovementContact: m••••••••@gmail.com
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.