E. SADA SHIVA PRASADMobile: +91-9160004925, +91-8332914035 ~ E-Mail: / essprasad@gmail.com

Job Objective

Seeking senior level assignments in Clinical Research with a leading organization of high repute

Profile Summary

A competent professional with an experience of over 10 years in:Clinical Database Programming Data/Team Management Clinical ResearchProcess Improvement Coordination & Liaison Project Management

Currently designated as Lead Engineer – with Pure Software Solutions and working as Project Consultant for the client, Oracle, Hyderabad.

Diverse experience of working for world’s leading pharma companies and strong knowledge of best practices followed across these companies for Clinical Data Management

Deft in interpreting & communicating required information to facilitate decision making process of the top management Experienced in planning & executing data capture and management tasks in a timely / accurate manner to ensure high

level quality & productivity of Clinical Data Management Skilled in effectively managing documents for streamlining systems to facilitate achievement of organizational objectives Proficient at carrying out Clinical Research beyond established markets Effective at building & maintaining relationships with the stakeholders and with a quick TAT of their queries Possess excellent communication, innovative, planning, negotiation, analytical and problem solving skills

Core Competencies

Protocol understanding and its interpretation in specifications, Designing eCRF, editing check programming (front end and backend), UAT, Go-Live and Data Management activities using Medidata Rave, Central Designer, Inform Architect, PhosCo tools, External Data Management, Data integration across different databases, conversion of custom data into SDTM datasets, SDTM datasets review and updation

Leading the development of specifications, implementation and testing for the development of eCRF Writing / reviewing detailed reports explaining about quality & its results, in terms of clinical research conducted;

creating and collating relevant documentation regarding the same Compiling data, innovating analysis & identifying the observed trends in data; conducting web search for required

data and analyzing the collected data Mapping documents with the information provided and forwarding it to the management to intimate about the basic

understanding of data Providing process improvement with a focus on streamlining process by adding value to the business & meeting client needs Coordinating & liaising with TA Lead, Medical Coder, Clinical Data Manager, Clinical Database Programmer & Clients Identifying team’s training & development needs and conducting appropriate training programmes to enhance their skills

Organisational Experience

Since Jan’14 Pure Software Solutions, Hyderabad as Lead Engineer – Resource Consultant – Client –Oracle India Pvt. Ltd., Hyderabad.

Role: Co-ordinating with Project Managers, Design Consultants, Technical Consultants, SDMs, Dev and QA Leads, for every

US project on weekly calls. Responsible for smooth delivery of projects (Inform Fast Starts and Fast Forwards) from resourcing point of view. Keep the communication intact with US collegues to match with US timings by working in night shift and respond to

their queries in time. Provide the weekly status report for all the projects to the higher management. Provide update on the upcoming projects’ pipeline. Alert the higher management well-in advance of the potential upcoming risk with projects or with resourcing. Manage off-shore resourcing including leaves, internal shuffles, trainings, project-plan updates etc.., with focus on

project deliveries. Provide inputs on process improvement to the management. Rolling out an updated resource sheet every day for the team to work on different projects.

Highlights: In the span of 1 year, worked on 196 total clarity requests for US region (26-FS,51-COs,60-TCCs,Scoping–38-21others) Received “High Flier” award from Pure Software Solutions as a token of appreciation Received appreciation mails from my Reporting manger, from the reporting Manager of PMs for good performance.

Jan’11-Jan’14 Tata Consultancy Services, Mumbai as IT Analyst – Lead Clinical Data Manager

Role: Developing full understanding of protocol including study documentation Preparing Quality Control Plan Gathering requirements for quality deliverable from the client Sending project plan to client after revising on regular basis Reviewing eCRF specifications prepared by Clinical Data Manager/ Clinical Database Programmer and finalizing guidelines Re-evaluating protocol deviation document; DVR specifications; test steps; UAT plan, performance & report; DMP Metrics; etc. Providing access in the:

o Preparation of Data Transfer Agreement for Vendors, SAE reconciliation and vendor data reconciliationo Monitoring data listings programs and dataset reviews for patient data consistency, quality & completeness

Managing discrepancy in accordance with the agreed timelines on front end checks, programmed consistency checks (back end)and escalating them in the clinical data to TA Lead & Clients as appropriate

Conducting studies for identifying issues with validation procedures and communicating the findings to TA Lead & Client Interfacing & interacting with TA Lead, sites, monitors, colleagues and client for site data related processes/ issues like

dataflow Utilizing appropriate data management tools to monitor quality & timeliness of data flow for assigned site Ensuring error free & quality data with no open queries before database lock, ICH GCP regulations and SOPs are

adhered to for data management activities Delivering applicable & required study metrics to Therapeutic Lead/ Project Manager Preparing the team members for audit ready documentation throughout the trial Attending relevant study teleconference with Clinical Data Managers & Client Updating Metrics (Snap Shots) on regular basis and send it to the team & internal customers

Highlights: Actively worked in Global Data Transfer Agreement for Bio Marker Data & Listings Programs for the client Instrumental in streamlining the Clinical Database programming and Quality Testing process in the project Received appreciations and promoted to next level for efficiently handling the assigned tasks Played a vital role in developing Global Library checks for the client on Central Designer tool

Sep’07–Jan’11 Novartis Healthcare Pvt. Ltd., Hyderabad, AP as EDC Trial Builder

Role: Involved in developing & programming EDC trials in PhosCo, Oracle Clinical, Central Designer tools for global Vaccines

Development clinical trials, phases I to IV, by setting up eCRFs, programming associated edit checks & data variable mappings for data extraction based on specifications provided by the Clinical Data Coordinators

Carried out thorough development testing (point-to-point) and delivered EDC trial packages & reports that are ready for user acceptance testing

Developed GRT reports by using SQL/PLSQL programming as per the requirement Outsourced studies to the CROs (Parexel, CMed, Covance, PPD & Quintiles) and guided them regarding study requirements Responsible for working on SOP preparation for the entire CRO trial designing process Worked for central lab external data loading into Novartis CT4 Database Supervised & monitored new joinees for handling CRO & EDC studies

Highlights: Received an Above and Beyond Award for working on global reports using SQL & PL/SQL Worked on creation of SOP on CRO trials management

Oct’06–Sept’07 Accenture Services Pvt. Ltd., Bangalore, Karnataka as Study Builder

Role: Created eCRFs using inform architect and associate appropriate edit checks Produced collation list & packages Coordinated & interacted with the global team members for uniformity of the study all over on regular basis Carried out peer review for all forms & rules

Highlight: Successfully created Study Specific Library by collecting study specific checks across trials of different therapeutic

areas

Feb’05–Oct’06 Biological E. Ltd., Hyderabad, Andhra Pradesh as Junior Scientific Officer

Role: Responsible for clinical lot production of Cell Culture based Measles Vaccine by using Chicken Embryo Fibroblast cells Carried out following activities for Cell Culture based JE & Dengue Vaccines:

o Revival of VERO, MDCK, MRC-5, PS etc., Cellso Subculture & Cell Bankingo Sterility Checking of Cells by Soya & Thio Brothso Mycoplasma Detection in Cell Cultureso Estimating DNA & Protein Content of Cellso Antigen Detection by ELISAo SDS-Page o Counting the number of Cells in each Flasko Literature Survey of Cell Historyo Preparation of Media, Reagents, Buffers, Trypsin, PBS, Sterility Media, etc.o Monitoring Area Cleaning, Equipment Cleaning & Sterilization Recordso Inventory Control

Highlights: Major Instruments Handled:

o Autoclave (Production Scale)o ELISA Reader (BioRad)o Lyophiliser (Virtis)o SDS-Page Unit (BioRad)o Spectrophotometer (Shimadzu)o Refrigerated Centrifuge (Beckmann)

Previous Experience

Jun’04-Dec’04 Biomed Informatics, Hyderabad, Andhra Pradesh as Research Associate

Trainings

Inform Architect Central Designer Medidata Rave Clinical Data Management PL/SQL SAS 9.0 Bio-informatics

Education

2011 MBA (HR) from Osmania University, Hyderabad 2004 Advanced PG Diploma in Bioinformatics from Medwin Hospitals, Hyderabad 2004 M.Sc. (Biotechnology) from Ganga Kaveri Institute of Science and Management (GKISM), Bangalore University, Bangalore2002 B.Sc. from S.R.R. Govt. Degree College, Kakatiya University, Karimnagar

Certification: SAS Certified

IT Skills

MS Office: Word, PowerPoint & Excel, Ms ProjectTools Used: Inform Architect, Central Designer, Medidata RAVE, Oracle Clinical,

Clintrial, Novartis EDC, I-Review & GPS-II, Clarity-PPMLanguages: C & VBScript, C# and .NET

EXTRACURRICULAR ACTIVITIES

Served as Member of Corporate Cricket Team at Novartis Functioned as Cultural Secretary at GKISM, Bangalore Won various awards at School and College levels in sports, elocution, essay writing and quiz competitions Active participation in corporate cultural activities

Social Engagement

Voluntarily donated funds to Parivartan Sandesh Foundation, NGO and Relief India Trust Served as Member of Green Peace, India Voluntary funds contribution to TCS Welfare Trust

Personal Details

Date of Birth: 10th August, 1980Present Address: Door No. 9-7-211/102, Shanta Lakeview Apartment, Near Mansarovar Heights, Manovikas

Nagar, Secunderabad – 500009, AP Permanent Address: Door No. 9-7-211/102, Shanta Lakeview Apartment, Near Mansarovar Heights, Manovikas Nagar,

Secunderabad – 500009, AP Languages Known: English, Hindi, Telugu, Kannada & MarathiLocation Preference: Hyderabad