Akash Bhosale
Senior Principal Clinical Data Standards Specialist
Hyderabad
Summary
Pharmaceutical professional with 14 years of experience - 9 years in Clinical Data Management and 5 years in Clinical Data Standards with expertise ranging from interpretation of Clinical Study Protocol (CSP) till submission of clinical data.
Overview
15
15
years of professional experience
1
1
Certification
Work History
Senior Principal Clinical Data Standards Specialist
Novartis Healthcare Pvt. Ltd.
04.2023 - Current
- Responsible for leading planning, development and implementation of Industry (CDISC and regulatory) compliant Clinical Data Standards, providing expert support to business users and teams on their use and in line with Clinical Data Standards strategy.
- Provide expert support ensuring development, implementation and timely availability of consistent, high quality Clinical Data Standards deliverables supporting the acquisition and tabulation and reporting of Clinical Trial data across global libraries including;
- Data collection tools in EDC (CRFs, edits checks, derivations, core configurations) and data transfer specifications
- Associated standard metadata, business rules and guidelines.
- Serves as primary contact for global data acquisition and tabulation for core global and/or assigned Therapeutic Area ensuring timely and quality deliverables.
- Accountable for driving efficient, high quality and timely implementation of new Data Acquisition and Tabulation standards and updates to standards in clinical systems including EDC, MDR and other global standards libraries including robust testing and validation
- Develop and manage updates to standard Data Transfer Specification (DTS) templates
- Create working practice for DTS Templates Standardization and associated Instruction Manual
- In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, lead accurate translation of scientific and analytical requirements into efficient, compliant standards.
- Provide mentoring and technical guidance to Clinical Data Standards associates; Contributes to effectiveness and development of talent. Create awareness about standards inventory and educate Data Managers on validating study specific requirements.
- Support and ensure appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed.
- Communicate effectively with partners and customers; Establish and maintain strong collaborative relationships with Data Operations, Biostatistics and Clinical Development groups supporting development and use of Clinical Data Standards.
- Lead and contribute to development, maintenance and training of relevant clinical standards systems and processes.
- Act as expert consultant providing Clinical Data Standards input to all relevant areas including; electronic data capture/database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management.
- Act as primary subject matter expert (SME) for assigned area providing support, consultation and training to end users. Create awareness about standards inventory and educate Data Managers on validating study specific requirements.
- Provide mentoring and technical guidance to Clinical Data Standards associates; Contributes to the effectiveness and development of talent.
- As needed, act as Clinical Standards representative leading and supporting data standards governance, process improvement initiatives and/or other non-clinical projects.
Principal Clinical Data Standards Specialist
Novartis Healthcare Pvt. Ltd.
04.2019 - 03.2023
Senior Clinical Data Specialist
Novartis Healthcare Pvt. Ltd.
04.2015 - 03.2019
Clinical Data Specialist
Novartis Healthcare Pvt. Ltd.
01.2013 - 03.2015
Clinical Data Reviewer
Tata Consultancy Services, Ltd
07.2011 - 01.2013
Junior Data Analyst
Cognizant Technology Solutions (India) Pvt. Ltd
08.2009 - 07.2011
Education
Master of Science - Clinical Research
Institute of Clinical Research
Mumbai, India 06.2007 - 2009.08
Bachelor of Science - Biotechnology
Padmashree Dr. D.Y.Patil College of A,C,S
Pune, India 08.2004 - 2007.04
Skills
Data Management
CDISC (CDASH)
CDISC (SDTM)
Medidata Rave
Metadata Management Systems
Content Development
Oracle Clinical
Project Management
InForm
Certification
CDISC Tabulate Certification
Accomplishments
· Clinical Data Management : Clinical study start-up, study conduct and study close out with specialized knowledge in creation of Case Report Forms (eCRF)/Data Transfer Specification (DTS), validation specifications, data review, query management and vendor management
· Clinical Data Standards : Clinical Data Interchange Standards Consortium (CDISC) standards with experience in Clinical Data Acquisition Standards Harmonization (CDASH) and Study Data Tabulation Model (SDTM).
· Systems: Medidata Rave, Oracle Clinical, Metadata Repository
· Project Management: Lead Data Manager (LDM) skilled in keeping timelines, risk management and delivering overall project deliverables.
Timeline
Senior Principal Clinical Data Standards Specialist
Novartis Healthcare Pvt. Ltd.
04.2023 - Current
Principal Clinical Data Standards Specialist
Novartis Healthcare Pvt. Ltd.
04.2019 - 03.2023
Senior Clinical Data Specialist
Novartis Healthcare Pvt. Ltd.
04.2015 - 03.2019
Clinical Data Specialist
Novartis Healthcare Pvt. Ltd.
01.2013 - 03.2015
Clinical Data Reviewer
Tata Consultancy Services, Ltd
07.2011 - 01.2013
Junior Data Analyst
Cognizant Technology Solutions (India) Pvt. Ltd
08.2009 - 07.2011
Master of Science - Clinical Research
Institute of Clinical Research
06.2007 - 2009.08
Bachelor of Science - Biotechnology
Padmashree Dr. D.Y.Patil College of A,C,S
08.2004 - 2007.04
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