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Shahnoor Sk

Project Manager @ Bayer | Data Analytics Agile Scrum

Greater Hyderabad Area

14+ years of work experience

Other
Feb 20197 yrs 5 mosPresent

Hyderabad, Telangana, India

- Proficient in validating critical systems, ensuring compliance with regulatory standards, including GxP and 21 CFR Part 11. - Utilized Lean and Six Sigma methodologies to identify areas for improvement and implement streamlined processes. - Leverage IT Operational processes involving EDC systems. - End-to End implementation of Metadata Repository system for CRF and Data model design. - Successfully led the implementation of Veeva CTMS, streamlining study planning, site management, and monitoring processes. - Conduct impact analysis on internal and third-party solutions during Releases. - Manage key stakeholders, vendors on related workstreams, delegating responsibilities and controlling the quality of deliverables.
Bayer Pharmaceuticals Ltd.
Feb 20197 yrs 5 mosPresent

Author and manage Validation documentation for systems like TrialGrid, MDR (Metadata Repository), RAVE, Veeva Clinical Vault inline with SOPs. Oversee and monitor migration of systems to Cloud based infrastructure like RAVEN, MTGM. Manage Quality documents and Change control in QDoc system. And Quality events like deviation, CAPA. Involved in ValDevOps project utilizing Valgenesis and Azure DevOps systems to work under modern environments - Agile and DevOps. Developed and maintained SOPs for various processes. Ensured that CAPA and deviation processes were aligned with regulatory standards and industry best practices. Expertise in evaluating systems risk / impact with Change implementation, SDLC concepts. Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors. Cross functional collaboration with internal business, technology teams & vendors (partners) to implement and maintain the systems. Ensure integrity of data generated and maintained by IT systems. Implement controls to prevent, detect, and correct data errors or discrepancies. Maintained comprehensive documentation to support audit readiness and regulatory inspections. Quality efficiency. Met tight deadlines to satisfy Project demands and timelines.
Tech Mahindra
Feb 20145 yrsJan 2019

Greater Hyderabad Area

- Worked with varied Clients and systems involving Roche, GSK, Genentech, Medtronic, Aspeter Hospital giving me opportunity to expand my knowledge / skillsets. - Implement a robust change control process to manage any modifications or updates to the IT systems. - Maintained comprehensive documentation to support audit readiness and regulatory inspections. - Managed full project lifecycles, from initiation to closure, ensuring timely and within-budget delivery. - Collaborated with business units to analyze and optimize existing processes, enhancing efficiency and compliance. - Leveraging my expertise in EMR and HIS systems, I contributed to the enhancement of healthcare delivery, streamlined clinical workflows, and improved patient outcomes.
Navayuga Infotech
Feb 201311 mosDec 2013

Hyderabad, Telangana, India

• Implemented web-based Healthcare Provider and Payer systems. Performed Gap Analysis based on RFP document, prepared Business Process and Context diagrams. • Worked on HL7 integration documentation for Labs / Radiology. • Ensured seamless interoperability between EMR and HIS systems, facilitating the exchange of patient data across different departments and healthcare providers.
Health Management & Research Institute, Hyderabad
Jan 20111 yr 4 mosApr 2012

Hyderabad, Telangana, India

• Worked on Application development involving Algorithms in Clinical decision support and involved in end-to-end implementation of Health Call Center (HACC), Mobile Health Vans and Telemedicine projects. • Conduct Gap Analysis & draft Solution Design for the newly proposed project, that works on PPP model. • Led Pre-sales activities as to draft responses to RFP released by potential clients. • Develop strategic business models and process improvement. • Applying for Grants / Awards to multilateral aid organization.

Education

Bioinformatics Institute of India

Master diploma

Bioinformatics Institute of India

20061 yr2007

PGDHM, Healthcare Management

Dr. Reddy's Foundation for Healthcare Mgnt

20031 yr2004

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Headline

Project Manager @ Bayer | Data Analytics Agile Scrum

About

With over 17 years as a Business Process Manager, I focus on optimizing processes and ensuring regulatory compliance. My expertise includes leveraging Lean and Six Sigma methodologies to enhance operational efficiency and implementing validated systems compliant with GxP and 21 CFR Part 11 standards. I have successfully contributed to the end-to-end implementation of Metadata Repository systems and Veeva CTMS, improving study planning and site management. By managing key stakeholders and vendors, I ensure the quality of deliverables while conducting impact analyses on internal and third-party solutions. My certifications in PMP and Agile Scrum reinforce my commitment to effective project, Product and process

Location

Greater Hyderabad Area

Work experience

Business Process Manager at Other, Feb 2019 - Present · 7 yrs 5 mos, Hyderabad, Telangana, India, - Proficient in validating critical systems, ensuring compliance with regulatory standards, including GxP and 21 CFR Part 11. - Utilized Lean and Six Sigma methodologies to identify areas for improvement and implement streamlined processes. - Leverage IT Operational processes involving EDC systems. - End-to End implementation of Metadata Repository system for CRF and Data model design. - Successfully led the implementation of Veeva CTMS, streamlining study planning, site management, and monitoring processes. - Conduct impact analysis on internal and third-party solutions during Releases. - Manage key stakeholders, vendors on related workstreams, delegating responsibilities and controlling the quality of deliverables.

Process Manager at Bayer Pharmaceuticals Ltd., Feb 2019 - Present · 7 yrs 5 mos, Author and manage Validation documentation for systems like TrialGrid, MDR (Metadata Repository), RAVE, Veeva Clinical Vault inline with SOPs. Oversee and monitor migration of systems to Cloud based infrastructure like RAVEN, MTGM. Manage Quality documents and Change control in QDoc system. And Quality events like deviation, CAPA. Involved in ValDevOps project utilizing Valgenesis and Azure DevOps systems to work under modern environments - Agile and DevOps. Developed and maintained SOPs for various processes. Ensured that CAPA and deviation processes were aligned with regulatory standards and industry best practices. Expertise in evaluating systems risk / impact with Change implementation, SDLC concepts. Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors. Cross functional collaboration with internal business, technology teams & vendors (partners) to implement and maintain the systems. Ensure integrity of data generated and maintained by IT systems. Implement controls to prevent, detect, and correct data errors or discrepancies. Maintained comprehensive documentation to support audit readiness and regulatory inspections. Quality efficiency. Met tight deadlines to satisfy Project demands and timelines.

Functional Consultant at Tech Mahindra, Feb 2014 - Jan 2019 · 5 yrs, Greater Hyderabad Area, - Worked with varied Clients and systems involving Roche, GSK, Genentech, Medtronic, Aspeter Hospital giving me opportunity to expand my knowledge / skillsets. - Implement a robust change control process to manage any modifications or updates to the IT systems. - Maintained comprehensive documentation to support audit readiness and regulatory inspections. - Managed full project lifecycles, from initiation to closure, ensuring timely and within-budget delivery. - Collaborated with business units to analyze and optimize existing processes, enhancing efficiency and compliance. - Leveraging my expertise in EMR and HIS systems, I contributed to the enhancement of healthcare delivery, streamlined clinical workflows, and improved patient outcomes.

Senior Business Analyst at Navayuga Infotech, Feb 2013 - Dec 2013 · 11 mos, Hyderabad, Telangana, India, • Implemented web-based Healthcare Provider and Payer systems. Performed Gap Analysis based on RFP document, prepared Business Process and Context diagrams. • Worked on HL7 integration documentation for Labs / Radiology. • Ensured seamless interoperability between EMR and HIS systems, facilitating the exchange of patient data across different departments and healthcare providers.

Business Analyst at Health Management & Research Institute, Hyderabad, Jan 2011 - Apr 2012 · 1 yr 4 mos, Hyderabad, Telangana, India, • Worked on Application development involving Algorithms in Clinical decision support and involved in end-to-end implementation of Health Call Center (HACC), Mobile Health Vans and Telemedicine projects. • Conduct Gap Analysis & draft Solution Design for the newly proposed project, that works on PPP model. • Led Pre-sales activities as to draft responses to RFP released by potential clients. • Develop strategic business models and process improvement. • Applying for Grants / Awards to multilateral aid organization.

Education

Master diploma, Bioinformatics Institute of India

PGDHM, Healthcare Management, Dr. Reddy's Foundation for Healthcare Mgnt