Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Certification
Languages
Interests
Timeline
Publications
Generic

ANN FEBA EBBY

Invermay,TAS

Summary

Experienced Clinical Data Manager and Programmer with a proven track record in enhancing the accuracy, compliance, and efficiency of clinical trials through robust data management and programming practices. Led end-to-end data validation processes and ensured alignment with regulatory standards across all study phases.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Clinical Data Manager

Medinix Information Systems GmbH
10.2023 - 05.2025

In addition to the clinical programming tasks, the following were added to the data management role:

  • Developed and implemented data validation processes to enhance accuracy and reliability of clinical trials.
  • Led data management initiatives to ensure compliance with regulatory standards and protocols.
  • Collaborated with cross-functional teams to streamline data collection procedures, improving efficiency.
  • Reviewing the draft protocol.
  • Creating the data management plan.
  • Reviewing the monitoring plan.
  • Specifying the eCRF implementation Medrio.
  • Query Management.
  • Creation of documentation for database lock/unlock.
  • Implementation of data management activities in accordance with the data management plan and the relevant guidelines.
  • Collaboration with the study team.
  • Review of the statistical analysis plan.
  • Review of the study report.
  • Directed the integration of new data management technologies, enhancing overall project performance and outcomes.

Clinical SAS Programmer

Medinix Information Systems GmbH
10.2021 - 10.2023

- Handling tasks in 1st and 2nd level customer support.

- Analyzing, evaluating, and resolving issues across various EDC systems with highest customer satisfaction resulting in company's increased reputation on trust and reliability.

- Handling study creation, lock, and archival requests in Medrio.

- Tracking and resolution of study-related issues and user support requests.

- Designing electronic questionnaires for capturing patient data in Medrio and Marwin, including the following steps:

  • Reviewing study protocols and active participation in protocol trainings.
  • Implementing study prototypes.
  • Creating study implementation specifications.
  • Implementation according to the specifications, documentation, and performing developer and QA testings.
  • Creating UAT plans.
  • Creating/uploading data entry guidelines and other study-related instructions.

Technical Analyst

Allianz Technology
10.2016 - 09.2018
  • Data Centre Infrastructure Management (October 2016 - September 2018)
  • Data Centre service management for customers in collaboration with IBM, Germany
  • Access to data centre facilities for customers in Europe, US, and UK with end to end support.
  • Quality control and assessment check before deployment.
  • Daily Task Management with IBM and other service providers for 100% customer satisfaction

System Software Engineer Trainee

Infosys Ltd.
05.2016 - 08.2016
  • Handled software projects using Python as the main language.

Education

Masters - Bioinformatics

University of Saarland

Bachelor of Technology - Bioinformatics

Sathyabama University
04.2016

All India Senior School Certificate Examination - undefined

Central Board of Secondary Education
05.2012

All India Senior Secondary Examination - undefined

Central Board of Secondary Education
05.2010

Skills

  • Electronic data capture and eCRF configuration
  • Medrio EDC expert user; Veeva and Marvin intermediate user
  • Clinical data management
  • Data validation techniques
  • Medical coding
  • Data reporting
  • Teamwork and collaboration
  • Ability to acquire knowledge quickly and grasp even the minutest details
  • Risk assessment and task prioritization
  • Strong conceptual, analytical and problem solving skills
  • Programming Languages : Python, R, basics of C and C
  • Big data management and excel intermediate user skills

Accomplishments

    - Collaborated and contributed in the initial Medrio study set up for Roche Diabetes Care projects.

    - Independently handled data management tasks for two major studies from their initial study phase to the clinical trial phase.

    - Significant role as a data manager for PERFORM-TSIX, REF-TSIX studies close out at Roche DIA.

Certification

- ITIL foundation

- C++

- EDCs such as Medrio, Veeva and Marvin.

- German B1 language.

Languages

English
Full Professional
Hindi
Professional Working
Malayalam
Native or Bilingual
German
Professional Working
Tamil
Limited Working
Spanish
Elementary

Interests

I am someone who loves the outdoor, meeting people and travelling I also engage in some poetry writing or blogging in my leisure time

I enjoy doing yoga and dancing for mindfulness and fitness

Timeline

Clinical Data Manager

Medinix Information Systems GmbH
10.2023 - 05.2025

Clinical SAS Programmer

Medinix Information Systems GmbH
10.2021 - 10.2023

Technical Analyst

Allianz Technology
10.2016 - 09.2018

System Software Engineer Trainee

Infosys Ltd.
05.2016 - 08.2016

Bachelor of Technology - Bioinformatics

Sathyabama University

All India Senior School Certificate Examination - undefined

Central Board of Secondary Education

All India Senior Secondary Examination - undefined

Central Board of Secondary Education

Masters - Bioinformatics

University of Saarland

Publications

  • Modeling and Docking of Anti- cancer herbal compounds
  • Seminar presentation at the 6th “International Symposium on Recent Trends in Macromolecular Structure and Function” conducted by the University of Madras, Chennai :
  • Http://www.sathyabamauniversity.ac.in/naac/2015/naac-volume3/files/basic-html/page882.html
  • Docking studies of Benzisoxazole analogues in White Spot Syndrome Virus
  • Research Journal of Pharmacy and Technology on “Docking studies of Benzisoxazole analogues in White Spot Syndrome Virus”.
  • Http://www.indianjournals.com/ijor.aspx?target=ijor:rjpt&volume=10&issue=8&article=011
ANN FEBA EBBY