Sreekanth Dandothkar
Chennai
Summary
Seasoned Clinical Data Monitoring & Management Manager with hands-on experience in Database Development, Data Modelling, CDISC Standards, Metadata Management, Clinical Data Flow and Reporting & Analytics. Overall 20+ years of experience in Biotechnology, Pharmaceutical, CRO and Life Sciences industry working in different roles & cross functional teams to ensure quality, accuracy & integrity of study data which enables seamless data flow across system which helps accelerates drug development process efficiently
Overview
20
20
years of professional experience
Work History
Associate Director, Asset Lead, Reporting and Analytics, CDS
Pfizer
Chennai
04.2019 - Current
- Works closely with CDS department roles and cross-functional study team members to create reporting and analytics solutions that support the quality and timely delivery of data management reports and visualizations required per standard and study-specific data review plans
- Ensure operational excellence in collaboration with partners (CDS/DM/Clinicians, Database Build, DMW, UAT, SMEs & FSPs) and colleagues for the application of standards and develop data cleaning reports in support of the data review plan/ reports/ Dashboards/ Automation utilities to ensure operational excellence across all DMM deliverables
- Serves on the data standards board as needed, and leads as needed implementation and where needed development of data management reporting standards
- Serve as a technical resource to the study teams for data visualization and reporting tools
- Led several semi-automated/ automated tools & utilities which helps to reduce the redundant work and improve the quality and timelines.
- Develops a talent base and anticipates development needs within the area of responsibility.
- Maintained positive relationships with stakeholders by responding promptly to inquiries, requests and complaints.
Senior Principal Clinical Data Standards Specialist
Novartis
Hyderabad
04.2018 - 04.2019
- Served as Primary Contact to ensure the appropriate and efficient governance and approval of global and project/study specific clinical data standards liaising with governance boards as needed
- Provided expert support ensuring the development, implementation and timely availability of consistent, high quality Clinical Data Standards deliverables supporting the acquisition and tabulation and/or analysis and reporting of Clinical Trial data across global libraries.
- Represented Data Standards team in the two weeks workshop to finalize specifications of Standard Edit checks held at Florham Park, NJ
Principal Clinical Standards Analyst
Novartis
Hyderabad
04.2017 - 04.2018
- Lead the accurate translation of scientific and analytical requirements into efficient, compliant standards, in collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development
Expert Clinical Data Standards Architect
Novartis
Hyderabad
04.2015 - 03.2017
- Act as an 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 and/or other clinical data management or analysis data and TFL-related systems
- Represented Data Standards team in the two weeks workshop to finalize specifications of Standard Edit checks held at Florham Park, NJ
- Lead role in developing Standardization of validation checks in OC (~2000 edit checks)
Senior Global Librarian I
Novartis
Hyderabad
04.2012 - 04.2015
- Provide timely guidance to Clinical Science/Business Units Standards office to interpret data collection requirements into data models and discuss with Novartis Clinical Data Standards Governance Board for input and approval
- Develop and maintain all standard objects, procedures, templates and views for OC standard Global Library.
Senior ECRF Developer
Novartis
07.2010 - 03.2012
- Lead and implemented first NCDS (Novartis Clinical Data Standards) trial using OC-RDC from Florham Park, NJ, USA
- Develop and maintain trial specific database applications, including eCRFs, validation programming, monitoring reports and database specifications in support of in-house and outsourced trials globally.
Sr. Programmer (Sr. Clinical Programmer Analyst)
PAREXEL
02.2008 - 07.2010
- General areas of responsibility include: database development for EDC and CDMS; data consistency check programming; import/export programming.
Technical Programmer
Accenture Services
02.2007 - 02.2008
- Writing Pl/SQL code on Oracle Clinical 4.5.1 to provide validation and derivation procedures (OC Validation Procs, Derivation Proc) across therapeutic areas
Analyst (QA)
Shantha Biotechnics Limited (A Merieux Alliance Company)
09.2004 - 01.2007
- Process Validation
- Equipment (Fermentors, Autoclaves, DHS etc.) Validation
- Facility (Area Qualification, Water) Validation
- Handling the Change Controls & CAPA
- Generating CFR 21 Part 11 compatible reports
- Coordinating the Audits conducted by various regulatory authorities and conducting internal mock audits before the regulatory audits.
Education
M.Sc. - Biotechnology
Presidency College
01.2004
GNIIT -
National Institute of Information Technology
01.1998
Skills
- Leading DRP (Data Review Programming) activities
- Patient profile
- Building, Managing & Grooming the team of technical experts
- Clinical Data Standards
- SDTM
- SAS
- JReview
- SQL/PLSQL
- Python
- Spotfire
- Electronic Data Capture (EDC)
- Clinical Data Management
- Analytical Skills
Websites
Awards
- VISION Award
- PQS Award
Timeline
Associate Director, Asset Lead, Reporting and Analytics, CDS
Pfizer
04.2019 - Current
Senior Principal Clinical Data Standards Specialist
Novartis
04.2018 - 04.2019
Principal Clinical Standards Analyst
Novartis
04.2017 - 04.2018
Expert Clinical Data Standards Architect
Novartis
04.2015 - 03.2017
Senior Global Librarian I
Novartis
04.2012 - 04.2015
Senior ECRF Developer
Novartis
07.2010 - 03.2012
Sr. Programmer (Sr. Clinical Programmer Analyst)
PAREXEL
02.2008 - 07.2010
Technical Programmer
Accenture Services
02.2007 - 02.2008
Analyst (QA)
Shantha Biotechnics Limited (A Merieux Alliance Company)
09.2004 - 01.2007
M.Sc. - Biotechnology
Presidency College
GNIIT -
National Institute of Information Technology
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