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Vijay Anand Thanakkan, PMP®

Data Science Enthusiastic - ICON ISS | Turning Data into Strategic Advantage | Biostatistics | Ex- GSK | Ex- PPD |

Greater Bengaluru Area

12+ years of work experience

ICON Strategic Solutions
Jan 20269 mosPresent

Bengaluru

Leadership & Oversight: Lead clinical data science operations to ensure departmental, program, and study objectives are consistently achieved to high quality standards. Project Delivery: Drive on-time completion of team deliverables while maintaining compliance with study timelines, quality benchmarks, and contractual obligations. Operational Excellence: Establish tracking and reporting mechanisms to monitor workload, enhance visibility, and optimize staff utilization across multiple projects. People Management: Provide technical and managerial leadership through mentorship, coaching, and structured training, fostering professional growth and team capability. Delegation & Development: Delegate responsibilities effectively to strengthen team ownership, encourage skill development, and improve operational efficiency. Strategic Initiatives: Support organizational initiatives aligned with strategic priorities, contributing to continuous improvement and effective change management. Stakeholder Collaboration: Partner with staff and management to build strong customer relationships and maintain collaborative stakeholder engagement. Talent & Capability Building: Contribute to recruitment activities and support capability development within the function to ensure long-term organizational strength. Subject Matter Expertise: Act as a subject matter expert when required, providing broader departmental support through additional leadership responsibilities. Readiness & Compliance: Ensure staff are trained on relevant tools, processes, and standards to maintain operational readiness and compliance.
GSK
Jan 20251 yr 1 moJan 2026

Bengaluru

Led and coordinated clinical programming efforts across multiple projects, ensuring timely delivery of outputs aligned with regulatory requirements and study objectives. Partnered closely with Biostatistics teams to design and implement robust programming solutions that enabled accurate interpretation of complex clinical trial data. Ensured strict compliance with CDISC standards and global regulatory guidelines, embedding quality and consistency in all programming deliverables. Provided proactive communication and updates to stakeholders, addressing queries, resolving data analysis issues, and supporting decision-making with clear, reliable insights.
GSK
Jul 20231 yr 6 mosDec 2024

Bengaluru

Served as SDTM Delivery Lead for FSO studies, providing strategic oversight and management of study teams to ensure timely and accurate deliverables. Developed deep expertise in the end-to-end clinical data lifecycle, including study design, conduct, and the transformation of raw data into standardized SDTM datasets. Directed delivery of high-quality SDTM datasets for critical Phase II and III clinical trials across diverse therapeutic areas such as oncology and infectious diseases. Implemented rigorous quality control processes, ensuring SDTM datasets met compliance standards and that all documentation was archived accurately and on time in the electronic Trial Master File (TMF) for audit readiness. Enhanced technical capabilities by undertaking advanced training in R and SAS, applying these skills to visualize and analyze clinical trial data for improved insights and efficiency.
GSK
Mar 20212 yrs 4 mosJun 2023

Bengaluru

Built and led high-performing teams by recruiting top talent and fostering a capability-driven environment, equipping staff with Veeva CDMS training to enable independent project management. Oversaw study team reporting and workload distribution, aligning resource allocation with professional development goals to maximize efficiency and growth. Established and maintained a Master Standard Library for data standards, driving consistency and achieving 70% compliance in new study builds.
PPD
Jun 20182 yrs 9 mosFeb 2021

Bangalore

Led technical operations for study-specific database design and build activities, ensuring delivery within project timelines and contractual commitments while providing technical consultancy and end-user support. Reviewed database designs for compliance and feasibility, maintaining alignment with system capabilities, sponsor specifications, and established standards; facilitated regular meetings with study teams during setup to ensure accuracy and effective communication. Contributed to departmental and corporate process improvement initiatives, serving as lead on key cross-functional projects to enhance efficiency, quality, and standardization across programming operations.
eClinical Solutions
Nov 20152 yrs 8 mosJun 2018

Bengaluru

Collaborated with cross-functional project teams to ensure timely, high-quality completion of EDC configurations aligned with study requirements. Provided technical guidance and mentorship to junior programmers, strengthening their troubleshooting skills and enhancing overall team capability in resolving EDC programming issues. Managed EDC projects end-to-end, coordinating timelines, allocating resources, and driving on-time delivery of critical study deliverables. Designed and configured EDC trials by translating trial design specifications into eCRFs, DVS, custom function integrations, and reporting outputs, ensuring accuracy and compliance.
Wincere Inc.
May 20141 yr 7 mosNov 2015

Bangalore

Served as Global Librarian in developing and maintaining libraries across multiple therapeutic areas using Medidata Rave EDC, ensuring consistency and efficiency in study builds. Acted as primary point of contact for sponsor studies, managing timelines and overseeing study deliverables to ensure successful completion within planned schedules. Led and supported study build activities in Medidata Rave, including eCRF analysis and design (folders, forms, fields, matrices, data dictionaries) as well as edit check programming (simple, complex, dynamic, and derivations).

Vijay’s AI Stack

claude
claude
gemini
gemini
grok
grok
manus
manus
ChatGPT
ChatGPT
Microsoft Copilot
Microsoft Copilot

Education

Bharath Institute Of Science And Technology

Master of Computer Applications (MCA), Computer Applications

Bharath Institute Of Science And Technology

20043 yrs2007

Bsc Computer Science, Computer Science

Bishop Heber College, Tiruchirappalli - 620 017.

20003 yrs2003

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Headline

Data Science Enthusiastic - ICON ISS | Turning Data into Strategic Advantage | Biostatistics | Ex- GSK | Ex- PPD |

About

Professional Summary Seasoned Project Manager and people leader with 17+ years of experience driving complex initiatives from inception to successful delivery. Backed by a strong technical foundation in computer science, I bring a solution‑oriented mindset to every challenge. I have a proven track record of boosting operational efficiency and consistently delivering projects under budget. My leadership style is built on inspiring excellence, fostering collaboration, and empowering teams to achieve their best. Committed to continuous growth through certifications, training, and industry best practices, I thrive in dynamic environments that demand strategic planning, agile execution, and resource optimization. My mission is to embrace new challenges, expand my skillset, and create meaningful impact for organizations. Core Skills Project Management & Delivery – Driving transformation and aligning projects with business goals Leadership & Team Development – Building high‑performing teams and mentoring for growth Strategic Planning & Execution – Designing roadmaps and delivering results under budget Operational Efficiency – Streamlining processes and enhancing productivity Tools & Technical Expertise Clinical Data Management Systems (EDC): Veeva CDMS, Medidata RAVE Standards: CDISC, SDTM Data Analysis & Reporting: SAS, R (Basics) Agile & Project Tools: JIRA, MS Project Analytics: Power BI

Location

Greater Bengaluru Area

AI stack

claude

gemini

grok

manus

ChatGPT

Microsoft Copilot

Work experience

Manager at ICON Strategic Solutions, Jan 2026 - Present · 9 mos, Bengaluru, Leadership & Oversight: Lead clinical data science operations to ensure departmental, program, and study objectives are consistently achieved to high quality standards. Project Delivery: Drive on-time completion of team deliverables while maintaining compliance with study timelines, quality benchmarks, and contractual obligations. Operational Excellence: Establish tracking and reporting mechanisms to monitor workload, enhance visibility, and optimize staff utilization across multiple projects. People Management: Provide technical and managerial leadership through mentorship, coaching, and structured training, fostering professional growth and team capability. Delegation & Development: Delegate responsibilities effectively to strengthen team ownership, encourage skill development, and improve operational efficiency. Strategic Initiatives: Support organizational initiatives aligned with strategic priorities, contributing to continuous improvement and effective change management. Stakeholder Collaboration: Partner with staff and management to build strong customer relationships and maintain collaborative stakeholder engagement. Talent & Capability Building: Contribute to recruitment activities and support capability development within the function to ensure long-term organizational strength. Subject Matter Expertise: Act as a subject matter expert when required, providing broader departmental support through additional leadership responsibilities. Readiness & Compliance: Ensure staff are trained on relevant tools, processes, and standards to maintain operational readiness and compliance.

Programming Manager - Biostatistics at GSK, Jan 2025 - Jan 2026 · 1 yr 1 mo, Bengaluru, Led and coordinated clinical programming efforts across multiple projects, ensuring timely delivery of outputs aligned with regulatory requirements and study objectives. Partnered closely with Biostatistics teams to design and implement robust programming solutions that enabled accurate interpretation of complex clinical trial data. Ensured strict compliance with CDISC standards and global regulatory guidelines, embedding quality and consistency in all programming deliverables. Provided proactive communication and updates to stakeholders, addressing queries, resolving data analysis issues, and supporting decision-making with clear, reliable insights.

Principal Project Lead at GSK, Jul 2023 - Dec 2024 · 1 yr 6 mos, Bengaluru, Served as SDTM Delivery Lead for FSO studies, providing strategic oversight and management of study teams to ensure timely and accurate deliverables. Developed deep expertise in the end-to-end clinical data lifecycle, including study design, conduct, and the transformation of raw data into standardized SDTM datasets. Directed delivery of high-quality SDTM datasets for critical Phase II and III clinical trials across diverse therapeutic areas such as oncology and infectious diseases. Implemented rigorous quality control processes, ensuring SDTM datasets met compliance standards and that all documentation was archived accurately and on time in the electronic Trial Master File (TMF) for audit readiness. Enhanced technical capabilities by undertaking advanced training in R and SAS, applying these skills to visualize and analyze clinical trial data for improved insights and efficiency.

Manager - Data Acquisition at GSK, Mar 2021 - Jun 2023 · 2 yrs 4 mos, Bengaluru, Built and led high-performing teams by recruiting top talent and fostering a capability-driven environment, equipping staff with Veeva CDMS training to enable independent project management. Oversaw study team reporting and workload distribution, aligning resource allocation with professional development goals to maximize efficiency and growth. Established and maintained a Master Standard Library for data standards, driving consistency and achieving 70% compliance in new study builds.

Sr. Lead Programmer at PPD, Jun 2018 - Feb 2021 · 2 yrs 9 mos, Bangalore, Led technical operations for study-specific database design and build activities, ensuring delivery within project timelines and contractual commitments while providing technical consultancy and end-user support. Reviewed database designs for compliance and feasibility, maintaining alignment with system capabilities, sponsor specifications, and established standards; facilitated regular meetings with study teams during setup to ensure accuracy and effective communication. Contributed to departmental and corporate process improvement initiatives, serving as lead on key cross-functional projects to enhance efficiency, quality, and standardization across programming operations.

Sr.EDC Developer at eClinical Solutions, Nov 2015 - Jun 2018 · 2 yrs 8 mos, Bengaluru, Collaborated with cross-functional project teams to ensure timely, high-quality completion of EDC configurations aligned with study requirements. Provided technical guidance and mentorship to junior programmers, strengthening their troubleshooting skills and enhancing overall team capability in resolving EDC programming issues. Managed EDC projects end-to-end, coordinating timelines, allocating resources, and driving on-time delivery of critical study deliverables. Designed and configured EDC trials by translating trial design specifications into eCRFs, DVS, custom function integrations, and reporting outputs, ensuring accuracy and compliance.

Consultant II - Clinical Programming at Wincere Inc., May 2014 - Nov 2015 · 1 yr 7 mos, Bangalore, Served as Global Librarian in developing and maintaining libraries across multiple therapeutic areas using Medidata Rave EDC, ensuring consistency and efficiency in study builds. Acted as primary point of contact for sponsor studies, managing timelines and overseeing study deliverables to ensure successful completion within planned schedules. Led and supported study build activities in Medidata Rave, including eCRF analysis and design (folders, forms, fields, matrices, data dictionaries) as well as edit check programming (simple, complex, dynamic, and derivations).

Education

Master of Computer Applications (MCA), Computer Applications, Bharath Institute Of Science And Technology

Bsc Computer Science, Computer Science, Bishop Heber College, Tiruchirappalli - 620 017.