Sada shiva profile

1. E. SADA SHIVA PRASAD
Mobile: +91-9160004925, ~ 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 12 years in:
Clinical Database Programming Data/Team Management Clinical Research
Process Improvement Coordination & Liaison Project Management
 Currently designated as Lead Engineer 2 – 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
 Goal settings, appraisal discussions and identifying key development areas for Team Leads and their respective team
members.
 Ensure that all the projects are implemented successfully, by reviewing documents and sending instructions to the
implementation engineers for successful installation of project in Customer environment.
Core Competencies
 Protocol understanding and its interpretation in specifications, Designing eCRF, edit check programming (front end
and backend), UAT, Go-Live and Data Management activities using Central Designer, Medidata Rave, 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
 Providingprocess improvementwithafocus onstreamlining 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
 Performing Objective settings for the Team Leads, constant follow-up, appraisal discussions followed by performance
ratings.
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.

2.  Rolling out an updated resource sheet every day for the team to work on different projects.
 Performing Trial development activities as per the clients’ requirements including Post-Go Live changes.
Highlights:
 Worked on 196 total clarity requests for US region (26-FS,51-COs,60-TCCs,Scoping–38-21others)
 Worked on 500+ requests to raise CRQs through PhaseForward Remedy for UAT, LIVE and TRN environments.
 Received “High Flier” award from Pure Software Solutions as a token of appreciation
 Received appreciations from my Director I am reporting to, and US PMs for good performance.
 Worked on 1500+ UAT/Live/TRN CRQs with 100 % quality.
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-evaluatingprotocol deviationdocument;DVRspecifications;teststeps;UAT plan, performance& report; DMP Metrics; etc.
 Providing access in the:
o Preparation of Data Transfer Agreement for Vendors, SAE reconciliation and vendor data reconciliation
o 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& interactingwithTALead, sites, monitors,colleaguesandclientforsitedatarelatedprocesses/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

3.  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., Cells
o Subculture & Cell Banking
o Sterility Checking of Cells by Soya & Thio Broths
o Mycoplasma Detection in Cell Cultures
o Estimating DNA & Protein Content of Cells
o Antigen Detection by ELISA
o SDS-Page
o Counting the number of Cells in each Flask
o Literature Survey of Cell History
o Preparation of Media, Reagents, Buffers, Trypsin, PBS, Sterility Media, etc.
o Monitoring Area Cleaning, Equipment Cleaning & Sterilization Records
o 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,
Bangalore
2002 B.Sc. from S.R.R. Govt. Degree College, Kakatiya University, Karimnagar
Certification:
 SAS Certified
 C#, .NET certification from Aptech
IT Skills
MS Office: Word, PowerPoint & Excel, Ms Project
Tools Used: Inform Architect, Central Designer, Medidata RAVE, Oracle Clinical,
Clintrial, Novartis EDC, I-Review & GPS-II, Clarity-PPM
Languages: C & VBScript, C# and .NET

4. 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, 1980
Present Address: Door No. 9-7-211/102, Shanta Lakeview Apartment, Near Mansarovar Heights, Manovikas
Nagar, Secunderabad, Telangana – 500009
Permanent Address: Door No. 9-7-211/102, Shanta Lakeview Apartment, Near Mansarovar Heights, Manovikas Nagar,
Secunderabad, Telangana – 500009
Languages Known: English, Hindi, Telugu, Kannada & Marathi
Location Preference: Hyderabad