Clinical Data Specialist
August 2015 --- December 2015
Clinical data specialist - involves the complete trial data management responsibilities, with a good knowledge starting from study startup to closure from the data management prospective. Clinical data specialist is involved with all job aspects performed by a senior clinical data manager.
Service Delivery Manager
October 2012 --- August 2015
SDM works closely with customers and cross-functional internal colleagues in order to understand and advocate customer’s operational needs, help the customer to adhere to the most effective processes, ensure service delivery in line with agreed service levels. Help customers and colleagues to understand the application and conduct of Health Sciences processes in an information-enabled environment, and ensure adherence to all relevant regulatory and procedural requirements. Roles & Responsibilities: 1. Supporting the live implementation of InForm clinical trials from the project initiation till the close down 2. Serving as a main escalation point for the supported customers 3. Liaise between Oracle Customer Support and the supported customers 4. Participating in regular /Adhoc customer meetings 5. Incident follow up meetings with the clients 6. Preparation and approval of Trial Change orders in post go live. 7. Assist the clinical team with study-related activities such as protocol creation & investigative site training. 8. Interact with sponsors and contractors related to specific clinical study and monitor the study progress from design to post Go-Live (Phase I - IV). 9. Good understanding of complete clinical trial development and management.
September 2009 --- May 2012
(HIPS) is based on the research in the fields of pharmaceutical sciences on campus of Saarland University and infection research at the Helmholtz Centre for Infection Research (HZI) in Braunschweig. Project details: Large Data correlation and organization without the loss of essential target inputs and discarding the nonessential data from experiments and storing them in a user understandable format is always a relatively huge task in Biological research area, to reduce this risk, Myxobase Explorer is a in-house database with a GUI providing comprehensive information of biological compounds, and correlated myxo-bacteria strain information. The main task is organizing a big amount of information into relational database with all necessary linkages and the design and implementation of a well functioning graphic user interface.
September 2007 --- September 2008
Worked as a programmer analyst in the Life science domain. Project:AMOS Study Set Up Client: Astra Zeneca Inc. Description: The project involves Clinical Trials development/customization activities in AMOS. The entire process involves customization/design of Electronic Case Report Form (eCRF) in AMOS. The project involves detailed review on each clinical trial customized. All the various modules that are implemented for any trial will be tested to verify that the development meets the client specification/CRFs. The verification and detailed analysis of CRFs and its amalgamation into eCRFs is the major task. Once the customization is through the team does an integration testing and send the tested source files, test, test reports. Website: http://www.astrazeneca.com
AdaptabilityCreative thinkingProblem solvingCommunicativeCompetitivenessFlexibilitySelf-confidence
Skills and Expertise
Delivery Managerdata managereCRFelectronic data capturetrial designraveoracle inform
Master of Science (MS) in Bioinformatics from Universität des Saarlandes in 2012
Bachelor's degree in Bioinformatics from Sathyabama Institute of Science and Technology in 2007