Ms Sujata Balaji
New York, NY 10022
Master of Science in Clinical Research Organization and Management (CROM) from Drexel University, PA GPA 4.0 - Received the Outstanding Academic Achievement Award for being the Top Academic Performer in the MS-CROM program.
Strong domain knowledge includes Regulatory Affairs (HIPAA 5010 and ICD-10 Final Rules), Compliance, Pharmaceutical Law, Clinical Data Management, Informatics and Health IT, Quality Assurance, Pharmacovigilance/Drug Safety, Clinical Research Product Development, Scientific/Medical Writing and Epidemiology.
Professional Certification in Drug Development and Clinical Research from Mercer County Community College, NJ
Master of Science (M.Sc) in Electronics, Gujarat University, India GPA 3.4
Bachelor of Science (B.Sc) in Electronic Science, St. Xavier’s College, India GPA 3.89
Experience working in the regulatory field on internal/due diligence audits and reviewing SOPs for multinational clients.
Experience in conceptualization, executing and compiling technology status reports for various scientific projects in the technology field.
Proficient in creating business requirement documents and functional specification documents.
Excellent skills in business analysis, data analysis, requirement gathering, business modeling and use case development.
Possess excellent analytical, leadership, communication, organizational and people management skills.
Software Development Life Cycle (SDLC) knowledge using Agile, RUP and Waterfall methodologies.
Business intelligence, master data management, and data warehousing systems knowledge
Business Analysis Tools : Excel, Power Point, Visio, Project, Rational Rose
Environments: Windows, Oracle 11g, SQL
Currently working on completing a Business Analyst Training program at Eglobalsys:
Projects worked on:
1. Business Entity - Third-Party Medical Billing Company serving multiple specialties, requiring a solution to increase automation, and to streamline the claims management process.
Description – Worked as a business analyst to collect, analyze and define business requirements, to enhance reporting and reimbursement capabilities, and in the implementation of a Practice Mangement/Medical Billing and Claims Management/EHR (Software-as-A-Service SAAS) software.
Further, demonstrated a strong knowledge and understanding of the requirements of the new 5010 HIPAA electronic transaction standard, effective Jan 1, 2012 and the ICD-10 final rule, effective Oct 1, 2013 (now delayed to Oct 1, 2014).
Defined newer requirements in Version 5010 claims such as, complete 9-digit zip code and billing address for providers and service facility locations, and the National Provider ID (NPI) only as a primary identifier, in place of SSN or Tax ID.
Also, an understanding of the new features of the ICD-10-CM and ICD-10-PCS code sets in terms of increased granularity and specificity in describing complex medical procedures, and the scope for adding new procedures, to name a few ID.
The solution focused on delivering robust reporting capabilities, creating deep functionalities for clinical workflow, shortened A/R cycle, increased practice efficiency and freeing up more staff time for revenue generating activities.
Worked on creating Scope and Business Objectives documents, Business Requirements Documents (BRD), Functional Specifications/Non-Functional Specification Documents(FSD/NFSD), Requirements Traceability Matrix.
2. Business Entity - A Healthcare Organization, which is both a hospital and an administrative arm of healthcare delivery, responsible as the chief non-commercial sponsor of clinical trials, for adverse event management and timely regulatory reporting.
Description Worked on identifying, analyzing and documenting the business requirements, and in the implementation of a safety reporting and pharmacovigilance software system, with a strong emphasis on Adverse Event Reporting and Risk Management. Demonstrated a strong understanding of the underlying principles of clinical safety and pharmacovigilance, which underscore the need for an organization to not only manage and report adverse event data, but also to analyze all available information to identify trends and establish the safety profile of every product.
The solution was designed to help the organization reduce safety risk for multiple product types, including drugs, devices, vaccines and combination products, provide international safety reports for clinical and post-marketing surveillance, improve the case processing life cycle and reduce data entry time. Business requirements were created to allow ad hoc reporting and personalized dashboards with standard and user-defined metrics/KPIs, shorten the medical review and coding process, and integrate with document management systems, business objects and clinical systems. Overall, the objective was to mitigate risks with increased compliance and process validation.
3. Business Entity - Mid-Size Pharmaceutical Company committed to the discovery, development and commercialization of potential transformational therapies.
Description Helped define, analyze and document the business requirements of the client in the implementation of a Clinical Trial Management System (CTMS)/Electronic Data Capture (EDC) system to efficiently manage clinical study related activities, electronic data capture, clinical data management, and technology integration.
Worked on defining key elements in the clinical trial management process such as Project Intelligence, Study Feasibility/ Start-Up and Initiation, On-Site Recruitment/Monitoring/Investigator Reimbursements/Study Close-Out where key functionalities were desired. The solution focused on streamlining trial activities, facilitating on-site recruitment goals, site performance metrics, financial tracking, ensuring robust global trial management, and seamless data integration from EDC to CTMS. The solution was also designed to provide input to a clinical analytics/business intelligence system to help with fact-based diagnostic and therapeutic decisions, capture revenues and save costs.
Past Auditing/Regulatory Experience: March 1997-Dec 1997
CA (CPA) Intern –S.R. Batliboi & Co/Ernst and Young, LLC, New Delhi, India
Worked as a CPA intern (CA intern) on various management audits (internal audits) and corporate audits for various multi-national and domestic clients –Worked on a team with the Manager or Senior Auditor to clients’ offices, reviewing and auditing their internal management SOPs, balance sheets and other financial and regulatory documents relevant to the audit and identifying discrepancies and violations, if any. Within the firm, participated in professional development and best practices training programs and interacted with various senior Managers and Partners and clients on assigned tasks.
Scientific Research/Project Experience:
• Department of Physics/Astrophysics – Materials Research Lab, University of Delhi, Delhi, India
Feb 1998- Sept 2000
Worked on identifying, scoping and writing literature reviews in electronic materials. Worked in the laboratory on developing potential applications and studying electrochemical processes involved in developing various electronic device structures.
• Research Scholar - Microelectronics Division, Department of Information Technology, Government. of India, India Jan 1995- Feb 1997
Worked as a Research Scholar on areas in semiconductor technologies. My work involved extensive literature reviews and the compilation of two Technology Status Reports “Technology Computer Aided design – An Overview” and “VLSI Semiconductor Technologies”. I was reporting to the (then) Director of the Microelectronics Division. My work involved the conceptualization, design and compilation of a technology roadmap for VLSI technologies.
• Research Scholar – Department of Electronics, Delhi University, India;
June 1994 – Jan 1995
Worked on identifying and scoping various areas in various semiconductor technologies and conducting literature reviews, and in drawing up research project plans.
• Internship - Data Communication Division, Indian Space Research Organization, Ahmedabad, India May 1993- Feb 1994
Worked as an individual contributor and a team player on the design and development of a serial communication card using microcontroller devices. Used computer-aided design software ORCAD to develop circuitry (circuit drafting) and the layout of the printed circuit board; carried out limited hardware testing. Worked under the supervision of the Project Director and interacted as team with several departments involved in the design of the device.
• Past Teaching/Education Experience:
• Plano Independent School District, Plano, TX - High-School Physics/Chemistry Teacher Aug 2007-Oct 2007
In Aug 2006, I started working on a professional alternative High-School Physical Sciences teacher Certification Program at the Collin County Community College, in Plano, TX. I received a Texas Probationary Teaching Certificate and was hired as a Physical Sciences (Integrated Physics/Chem) High-School Science teacher by the Plano Independent School District in June 2007.
I worked as a team member under the head of the Science Department and developed lesson plans and curriculum; Attended over 56 hours of Professional development courses as part of the School District Training for new teachers, proctored PSAT examinations;
• Middle/High-School Science Substitute Teacher – Bridgewater-Raritan School District, NJ April 2008-May 2009
Worked as a substitute science teacher for High and Sr. High-School Physics/Chemistry and Math classes.
• Master of Science (M.S.) Clinical Research Organization and Management – College of Medicine, Drexel University, PA 2010 - 2012 GPA 4.0
• Drug Development/Clinical Research Certification – Mercer County Community College, West Windsor, NJ 2009-2010 Grade: A
• Master of Science (M.Sc) Electronic Science - School of Sciences, Gujarat University, India 1992-1994 GPA 3.4
• Bachelor of Science ( B.Sc) (Physics,Chemistry, Electronic Science) - St. Xavier’s College, Gujarat University, India 1989-1992 GPA 3.89
• Medical Transcription Diploma – At-Home Professions, Colorado. 2001-2002
• Other Information
Student Member – Drug information Association
WES Credential Evaluation and Authentication Report Available for B.Sc and M.Sc Degrees