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[QUOTE=Guest-IJT;106794][b]Name [/b]: Ankit Jain [b]Email [/b]: ankitjn42 AT gmail.com [b]Designation / Skillset[/b] : Project Coordinator Working as a Project coordinator in The Cognition Group from 01st Jan 2011 till Date. Also worked as a Trainee Clinical Research Coordinator in Apollo Hospital from 01st 2010 to 31st Dec 2010. [u][b]Resume[/b][/u] : OBJECTIVE To strive for Excellence in the field of Clinical research – with dedication, focus, proactive approach, positive attitude and passion. Seeking the growth oriented position in a reputed organization and to obtain a position of Clinical research associates where I can utilize my knowledge and skills in the best possible way for the fulfillment of organizational goals. CAREER PROFILE - Knowledge of clinical Trial data like Demographic Data, Adverse Events (AE), and Serious Adverse Events (SAE). - Good Comprehension of FDA and guidelines, Good Clinical Practice (GCP), International Conference of Harmonization (ICH) and other regulatory guidelines (NDA) and Schedule Y. - Knowledgeable in all areas of research including IRB protocol submissions, on-going regulatory and IRB phases and IND safety reporting. - Comprehension knowledge or monitoring procedures. - Comprehension knowledge of clinical trial process. - Comprehension knowledge of various Psychiatric disorder rating scales like PANSS & YMRS - Comprehensive knowledge of S.O.P.’s for site monitoring. - Demonstrate understanding of medical terminology ACADEMIC RECORD Qualification \ Specialization University\Institution Year of Passing Percentage Acquired Post-graduate Certified Course Clinical research Apollo Hospital- Delhi 2010 64% B.Pharma R.G.P.V University (M.P) 2009 68% 12th - Science E.L.C School Sagar (M.P) 2003 59% 10th - Class St. Joseph Convent Sagar (M.P) 2001 55% PROFESSIONAL EXPEREINCE COMPANY THE COGNITION GROUP (Cogtest Services Pvt Ltd)- Gurgaon CLIENT Merck &, Shering Plough PROJECT Overall Monitoring and Management of the Clinical studies (Psychiatric Disorders like Bipolar Depression and Schizophrenia). Duration January 2011 to Till Date. Role Played Project Coordinator [b]Responsibilities Held [/b]: [b]Project Management [/b]: - Attending Kick-Off meeting with the client to do the requirement analysis. - Preparing project management plan for entire cycle of the project. - Identifying and forecasting the risk and benefit issues arising in the project. - Working on the Project Scope and its attributes. - Acting as a primary contact with the client. - Planning and monitoring of execution of projects to ensure timely and effective completion of project assignment. - Resource and task scheduling and final execution and close out of the project. - Preparing and reviewing documentation related to the projects. - Work collaboratively with other functional teams (development, multimedia, data management, business development, finance, quality assurance, IT and customer service). - Prepare and face internal and external audits. - Support business development activities including data mining and analysis as per client’s requirement. [b]Data management [/b]: - Data transfer specification document and managing the data queries related to trials. Coordination with Data programming team on the data sets and variables generation for the tests ( in-house ) [b]Study Analysis Plan [/b]: - Coordinate with the lead statistician on the statistics procedure for the Datasets. Interim analysis of the datasets as per the data transfer specification. Submit study reports to the client. [b]Clinical Research Operation [/b]: - Updating the site CRA’s, CRC’s and sponsors regarding the study status (rater training and certification updates), weekly and monthly report generation, attending the weekly vendor teleconference meetings and other meetings with the sponsors. - Generating project documents, validation documents and procedural Manuals. - Reviewing, Tracking and monitoring of project (in-house) progress along with other team members and generating project status reports. - Recruiting key opinion leaders on a strategic mode for administrating different depression measuring scales and as an expert trainer/rater in the study. - Monitoring and following up with Investigators for the timely completion of projects. - Undertaking training programs and preparing study related manuals to be presented at Investigator’s meetings. - Updating and maintaining the Trial Master File. - Assisting in statistically analyzing the rater ratings and preparing rater training reports for the sponsor. - Preparing and implementing SOPs and Manuals for clinical operations. - Participate in the study related Teleconferences and/or meeting with the line manager in order to discuss any study related issues. - Ensuring regular communication with the line manager and updating on the study/project status. TRAINING PROFILE Worked as Trainee Clinical Research Coordinator in Apollo Hospital Education & Research Foundation New Delhi from January 2010 to December 2010. PROJECTS HANDLED - A Phase III study on Cardiac Patients with Hyponatraemia. - A Phase IV study on Acute Myocardial Infraction. - A Phase IV study on Chronic Kidney Disease. - Research Paper on Antiarrhythymic Agent. SAS KNOWLEDGE AND SKILLS - Good proficiency in reading SAS data sets and creating variables. - Knowledge in creating SAS data sets reading raw data files both column and formatted input, examining data errors, assigning variable attributes and reading the data from excel spreadsheets. - Efficient in combining data sets like concatenating and merging SAS data sets. - Knowledge in producing summary reports like Proc freq, Means, Report, Tabulate output. - Knowledge on listing and summary tables to report the results of clinical data files. - Knowledge in retrieving data from different databases like, SQL, Using SAS applications. - Created tables by using Proc Transpose, Proc Tabulate, Proc Format, and Proc Report. - Analyzed the data by SAS/Stat (Proc GLM, Proc Reg, Proc means, Proc Univariate) - Delivering output by using ODS ( PDF, RTF formats) - Report Generation in CHART and PLOT formats by using SAS/GRAPH. - Testing and Debugging of SAS Code. TRAINING AND CONFERENCES - Trained In EDC tools – Inform - Industrial visit at GLENMARK Biotech BADDI (H.P) - One Month Industrial Training at LUPIN Ltd Mandideep (Bhopal) - Attended seminar on Clinical trial on children in Niper Chandigarh - Observed Phase – I trials in PGIMER, Chandigarh - Seminar attended on GCP at Apollo hospital, Delhi conducted by WHO. DECLARIATION I acknowledge that the above mentioned information is true and correct to the best of my knowledge. [b]DATE [/b]: ANKIT JAIN ------------------------------------------------------- [b]More Information about this submission and submitter [/b]:- ___________________________________________________ [b]Submission ID [/b]: 4195534 [b]Date & Time [/b]: 31st May 2011 4:47 PM (UTC) [b]IP Address [/b]: 14.99.215.36 [b]Browser Info [/b]: Mozilla/4.0 (compatible; MSIE 8.0; Windows NT 5.1; Trident/4.0; EasyBits GO v1.0; .NET CLR 1.1.4322; .NET CLR 2.0.50727; .NET CLR 3.0.4506.2152; .NET CLR 3.5.30729; InfoPath.2) Predicted Country []: --[/QUOTE]
