Clinical Management Research Data Entry Assistant
Raja Sajinraj Rajendran
Present Address: Contact details:
C-8 /2:1 Akshay C.H.S, Cell: +91-982*******
Sector-15 Airoli, +91-983*******, +91-022-
Navi Mumbai, Maharashtra (state). E-mail I.D: email@example.com
Birth Date: 7th April 1988
English, Hindi, Marathi, Malayalam.
I would like to take a position where I can justify my knowledge and skills gained during my professional studies and my qualities of a fast learner and ability to take new challenges.
I like to grow positively and to be a contributory factor to the growth of the organization by the way of continuous learning and enhancement of personal potential.
“Success occurs only when opportunities and preparations meet”
• B.Sc Biotechnology with inputs of Microbiology.
• One year full time degree in Advanced Post Graduate Diploma in Clinical Research Management (APGDCRM).
• Well versed with various packages of Microsoft office.
• Excellent in communication.
• One year full time program in Advance Post Graduate Diploma in Clinical Research Management (APGDCRM) from CREMA (Mumbai)
• Graduate in Biotechnology from University of Mumbai.
Jr. Safety Data Analyst at Sciformix Technologies Pvt. Ltd.
January 2012 - Present
• Receive and accurately document Adverse Event as per the Standard Operating procedure.
• Achieve objectives for responsiveness, cycle time and quality standards by managing personal productivity and by timely and appropriately responding to inquiries and escalating cases as appropriate.
• Identify crisis events, trends and shifts in inquiry volume, reasons for the change and recommend action to Managers.
• Narrative writing, case processing as recommended by USFDA in compliance with 21CFR11 as per Good Pharmacovigilance Practices.
• Good knowledge of coding of medical history, drugs and adverse event terms using WHO drug dictionary and MedDRA (Version 14.1), knowledge of CIOMS forms and reporting.
• Assess all Adverse Events for seriousness, causality and execute case assessment and update the database as required.
• Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.
• Performing Data entry work for Abbreviated Literature Cases using Oracle Argus Version 6.0.1.
• Ensure compliance of operations with governing regulatory requirements.
• Assume accountability for a culture of high customer services.
• Perform any other support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps, reconciliation of data from multiple sources including literature search.
Clinical Trial Assistant in Site Identification and Feasibility department at Quintiles Research (India) Private Ltd.
31- Dec 2010 to January 2012
• New Site Identification using databases like clinicaltrials.gov, ctri.nic.in, journals and references.
• To analyze & obtain data from sites perspective which is a must for recommending investigator/site for a clinical trial.
• To evaluate and select site for conducting clinical trials.
• Co-ordinating with sites for procuring the study specific documents prior to selection of the sites for a specific study
• Contacting sites to check the availability of protocol specific feasibility requirements for new clinical trials.
Trainings & seminars:
• Underwent 15 days training on’ Human Cell Culture & Chromosomal Analysis’ at Mahatma Gandhi Mission Hospital, Vashi, Navi Mumbai.
• Attended training in Tissue Banking department at Tata Memorial Hospital.
• Attended seminar conducted by the World Courier on “Dangerous Good Awareness with Concentration on Preparing, Handling & transportation Infectious Substances by Air”.
• Underwent training in Central Government owned Lab for testing of Imported food & Milk products (Pilot Test House, Mumbai)
• Attended 2 days training on Start up of Clinical trials.
• Attended Advanced Good Clinical Practice Training conducted in K.E.M Hospital Mumbai.
• Attended voice and accent training by open doors solution conducted at Sciformix Technologies Pvt. Ltd- Mumbai.
• Completed training schedule of FDA’s “The Past, Present, and Future of FDA Human Regualtion.”
Achievements & Awards:
• Achieved ‘A’ grade in a Government approved syllabus of Maharashtra Cadet Corps.
• Bagged first prize in Drama on AIDS Awareness conducted by Sampark-Navi Mumbai Festival.
• Secured second prize in the event Ad-Mad show at inter-Collegiate level conducted by Vivekanand Education Society’s College, Mumbai.
Place: Mumbai Raja Sajinraj Rajendran
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