Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Languages
Personal Information
Hobbies and Interests
Professional Highlights
Timeline
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S. SHAHUL HAMEED

Chennai

Summary

Data Management professional with over 10 years’ work experience as Project Data Manager in CROs, specializing in ensuring data integrity, regulatory compliance, and timely project delivery for global clinical trials. Successfully managed the full data management lifecycle for over 15 clinical trials, from study start-up to database lock, consistently ensuring data integrity and adherence to regulatory guidelines. Led a team of data management professionals, providing guidance and mentorship to ensure high-quality deliverables and adherence to best practices. Proactively managed data discrepancies, conducting root cause analyses, and implementing corrective and preventive actions to maintain data integrity and minimize risks. Developed and implemented a streamlined data management process that resulted in a 20% increase in efficiency and data accuracy, demonstrating expertise in process optimization. Expert in using clinical data management systems, including Oracle Clinical, Inform, and RAVE, as well as electronic data capture (EDC) systems. Proficient in developing and implementing Data Management Plans (DMPs) in alignment with study protocols and regulatory requirements. Skilled in performing User Acceptance Testing (UAT) to validate system functionality and ensure data integrity within clinical trial management systems. Experienced in conducting meticulous data reconciliation, including external data and SAE reconciliation, to ensure accuracy and consistency of critical trial data. Adept at collaborating effectively with cross-functional teams, including clinical data managers, study coordinators, and project managers, to achieve project goals and ensure seamless data management processes. Recognized for outstanding performance and teamwork in data management and project delivery, demonstrating a strong work ethic and collaborative approach. Possesses a strong understanding of therapeutic areas, indications, and data capture standards specific to the pharmaceutical industry. Committed to maintaining an up-to-date knowledge of industry trends and best practices in clinical data management to drive continuous improvement.

Overview

17
17
years of professional experience
1
1
Certification

Work History

Senior Process Expert

Accenture Services Pvt. Ltd
Chennai
09.2011
  • Generated and reviewed Case Report Form (CRF) Summary Reports, providing insights into data trends, potential issues, and overall data quality to inform decision-making and support study monitoring
  • Collaborated effectively with team leads and onshore resources to ensure data quality, timely deliverables, and seamless project execution
  • Developed and maintained a strong understanding of clinical data validation processes, industry standards, and relevant technologies, ensuring the accuracy and completeness of clinical trial data
  • Reviewed and resolved system-identified and manual data discrepancies, utilizing knowledge of clinical data standards and study protocols to ensure data integrity
  • Drafted clear and concise data clarification forms to address data queries and inconsistencies, facilitating effective communication with clinical sites and contributing to data accuracy

Team Leader

Cognizant Technology Solutions
Bangalore
03.2022 - 05.2024
  • Provided comprehensive training to data management teams on study-specific procedures, data management systems, and industry standards, ensuring a high level of competency and performance
  • Led and mentored a team of data management professionals, ensuring the delivery of high-quality work and fostering a collaborative and supportive team environment
  • Oversaw all data management activities for multiple clinical trials, ensuring adherence to industry best practices, regulatory guidelines (e.g., ICH-GCP), and study-specific requirements
  • Developed and implemented comprehensive Data Management Plans (DMPs) to ensure alignment with study protocols, data standards, and regulatory expectations
  • Proactively identified and resolved data discrepancies, conducting thorough root cause analyses and implementing corrective and preventive actions to maintain data integrity and minimize study risks
  • Led the process of assessing the impact of protocol amendments on data management processes, implementing necessary adjustments, and ensuring data consistency throughout study modifications
  • Maintained meticulous study documentation, including data management plans, validation reports, and query logs, ensuring compliance with industry standards and audit readiness
  • Generated comprehensive reports and data visualizations, providing stakeholders with actionable insights to support decision-making and study monitoring

Senior Clinical Data Coordinator

Icon Clinical Research
Chennai
10.2015 - 03.2022
  • Ensured data accuracy and consistency through meticulous external data reconciliation and SAE (Serious Adverse Event) reconciliation, contributing to the reliability and integrity of critical trial data
  • Managed study documentation meticulously, ensuring adherence to industry standards (e.g., ICH-GCP, DCRF), regulatory requirements, and Sponsor-specific guidelines
  • Performed comprehensive User Acceptance Testing (UAT) on clinical trial management systems, validating system functionality, data integrity, and reporting capabilities to ensure compliance and data accuracy
  • Collaborated effectively with Clinical Data Management (CDM) teams to address and resolve data management issues, ensuring timely solutions and contributing to overall study data quality
  • Developed and maintained essential study documents, including electronic Case Report Forms (eCRFs), Data Validation Specifications, and study-specific procedural documents, to ensure clarity, consistency, and compliance in data management processes
  • Provided training and guidance to junior Clinical Data Coordinators, fostering their professional development and strengthening the team's overall data management expertise

Senior Clinical Data Coordinator

Quintiles
Bangalore
09.2011 - 07.2013
  • Served as a Data Operations Coordinator (DOC), providing expertise and guidance to the clinical data management team, supporting their professional development, and ensuring efficient data management operations
  • Successfully managed the full data management lifecycle for global clinical trials, from study start-up to database lock, ensuring high-quality data and timely project completion
  • Ensured data quality through rigorous quality control procedures, including data review, query resolution, and database validation checks, adhering to industry best practices and regulatory guidelines
  • Proactively identified and resolved data management issues, escalating complex challenges as needed to ensure timely and effective solutions
  • Managed project timelines efficiently, coordinating data management activities to meet key milestones and deadlines

Clinical Data Coordinator

ICON Clinical Research Pvt. Ltd
Chennai
05.2007 - 09.2011
  • Generated and executed data queries to clarify data points and resolve discrepancies, collaborating effectively with clinical sites to obtain accurate and complete information, and ensuring data quality for analysis
  • Assisted with the validation of edit check programs, contributing to enhanced data accuracy, efficient data entry, and improved data quality within the electronic data capture (EDC) system
  • Participated actively in project meetings as a data management representative, providing data-driven updates, collaborating with cross-functional teams, and contributing to informed decision-making
  • Reviewed and ensured the accuracy and consistency of Case Report Form (CRF) data, adhering to established data handling conventions, guidelines, and study-specific requirements
  • Conducted rigorous quality reviews to identify and resolve data discrepancies, ensuring data integrity, compliance with study protocols, and the reliability of clinical trial data
  • Prepared and maintained comprehensive database test documentation, supporting data validation and quality control processes, and contributing to data integrity and regulatory compliance

Education

MSc. - Biotechnology

Mohamed Sathak College of Arts & Science
Chennai, Madras

BSc. - Life Sciences

Sri Venkateswara College
New Delhi, Delhi

Skills

  • Clinical Data Management Proficiency
  • Regulatory Compliance Management
  • Team Project Leadership
  • Process Optimization
  • Written Communication Proficiency
  • Cross-Functional Collaboration
  • Collaborative Problem Solving
  • Leadership
  • Analytical Problem-Solving
  • Guiding Colleagues
  • Employee Training
  • Prioritization Skills
  • Thorough Review Skills
  • Structured Planning
  • Responsive to Change

Certification

  • Advanced PC Applications
  • Designing and Implementing Databases using SQL Server 2000 and RDBMS
  • Webdesigning and JAVA Script
  • C++ and Object Oriented Programming
  • Project Management Foundations
  • Microsoft Power BI Basics

Accomplishments

  • Successfully managed over 15 clinical trials, ensuring timely data collection, query management, and database locks, demonstrating expertise in project management and data integrity.
  • Developed and implemented a streamlined data management process resulting in a 20% increase in efficiency and data accuracy, highlighting process improvement and optimization skills.

Languages

English
Hindi
Tamil

Personal Information

Date of Birth: 06/04/81

Hobbies and Interests

  • Data Visualization and Analytics (e.g., exploring new visualization techniques, working with personal data projects)
  • Industry Events and Webinars (e.g., attending conferences, participating in online forums related to data management in clinical research)
  • Mentoring and Volunteering (e.g., guiding aspiring data professionals, supporting science-related initiatives)
  • Wellness and Mindfulness (e.g., practicing yoga or meditation, engaging in activities that promote work-life balance)
  • Travel and Cultural Exploration (e.g., experiencing new cultures, broadening perspectives through travel)

Professional Highlights

Skilled data management professional with 15 years of experience in end-to-end Data Management activities seeking to leverage expertise in data integrity, regulatory compliance, and clinical data systems. Driven to ensure the accuracy and efficiency of clinical data, contributing to the delivery of innovative healthcare solutions.

Timeline

Team Leader

Cognizant Technology Solutions
03.2022 - 05.2024

Senior Clinical Data Coordinator

Icon Clinical Research
10.2015 - 03.2022

Senior Process Expert

Accenture Services Pvt. Ltd
09.2011

Senior Clinical Data Coordinator

Quintiles
09.2011 - 07.2013

Clinical Data Coordinator

ICON Clinical Research Pvt. Ltd
05.2007 - 09.2011

MSc. - Biotechnology

Mohamed Sathak College of Arts & Science

BSc. - Life Sciences

Sri Venkateswara College
S. SHAHUL HAMEED