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[QUOTE=Guest;263056]Shobha Manne [b][u]Email [/u][/b]: shobhamanne AT gmail.com [b][u]Work Experience [/u][/b]: o Clinical Supply Documentation Specialist at Novartis Health Care Pvt. Ltd Sep 2010 till date o Clinical Research Associate from Aug 2009 till Aug 2010, Maya Clinicals (Clinical Research Organization), Banjara Hills, Hyderabad. o Clinical Research Coordinator from Feb 2008 till Aug 2009, Kamineni Hospital, L.B Nagar, Hyderabad. [b][u]o Trainee Study Coordinator [/u][/b]: April 07 to July 07 in Manipal Acunova, KMC Hospital, Mangalore. [b][u]Job Responsibilities [/u][/b]: [b][u]As Clinical Supply Documentation Specialist [/u][/b]: o Trained new colleagues on complete process labeling, packaging design o Trained Supply Chain Managers and Trial Managers on PINGU tool o Establishes the packaging documentation (including label design and randomization) for Investigational Medicinal Products for clinical studies (Phase I-IV) according to GMP, GCP and other regulations. o Vendor management for External label, responsibilities included here are selection of the vendor and working through the finances for the bulk labels at project level and also approval of the label proofs and providing required information to QA for the approvals externally printed booklet labels o Have been part of Deviation & Complaint Certification Program for DSM and been the owner and investigator of several deviations o Key user for deviation and complain handling tool o Receives clinical order (CPR) and study specific information (e.g. packaging design, batch allocation) from DSM Study Manager o Complements data entry in the DSM Planning Tool for order scheduling o Generates labels according to country-specific requirements (following a general setup) and gets approval from the DRA contacts in the involved Country Pharma Organizations and the DSM Study Manager o Performs randomization, gets approval from BQA and sets up text for emergency codes o Creates the packaging documentation for medication of individual studies according to predefined study design o Ensures compliance with study specific and QA requirements o Performs Line Unit Check of packaging documentation for clinical supplies o Interacts with DSM Study Manager to assure timely delivery of documentation to printing and packaging site [ b][u]As a Clinical Research Associate [/u][/b]: o Conduct of Site initiation Visits (10), interim monitoring visits(23) o Conduct of study close out visits (9). o Preparation of project proposals and budget. o Production of comprehensive visit reports and status reports o Conducting feasibility studies for upcoming projects o Participating in discussions with the sponsors. o Drug accountability o Communicating with site personnel and investigators o Resolving sponsor specific queries o Submission of study documents to Ethics Committee o Preparation and dispatch of high quality SIV Packages to sites o Made payments to vendors o Preparation and distribution of meeting minutes. o Coordinating in Preparing News letter o Training site pharmacists on IWRS o Coordinating with Drug Depot [b][u]Project [/u][/b]: o Phase IIb prospective, randomized, double-blind, placebo controlled, multi-center, and dose escalation study of IP in acute ischemic stroke patients. [b][u]As a Clinical Research Coordinator [/u][/b]: o Projects handled in following therapeutic areas o Schizophrenia o Depression o Mania o Allergic Rhinitis o Asthma o Septic Shock o Trauma ( risk of significant hemorrhage) o Hepatitis – B o Chronic renal insufficiency [b][u]Additional Trainings Done [/u][/b]: o Cross Cultural interaction Training o Corporate- Values and Behavior o Investigational Medical Product management o Time Management [b][u]Achievements AT Novartis [/u][/b]: o Nominated for Global Experience Program o Above and beyond award for success of DSM Carnival o Nominated as Key user for AQWA – deviation and complaining handling tool o Subject Matter expert for Packaging Instruction Generation Utility tool o Completed Ist Part of Phrase library data base Validation – translations data base o Introduced checklist for the easy availability of the data for label design and packaging design [b][u]Academic Profile [/u][/b]: MSc Clinical Research – 2005 - 2007 Institute of Clinical Research (India), Bangalore. Bsc Biotechnology – 2002 - 2005 St. Joseph’s College, Bangalore. I hereby declare that the information given above is correct to best of my knowledge [b][u]Place [/u][/b]: - Hyderabad Shobha Manne[/QUOTE]
