Summary
Overview
Work History
Education
Skills
Accomplishments
Technical skills
Timeline
Generic
Kabelan M

Kabelan M

Senior Data Manager / Project Lead
Coimbatore

Summary

Organized professional with 5 years' experience in clinical research, study setup, and data management. Skilled in database design, clinical systems, and managing multiple projects. Proven ability to lead teams, forecast projects, meet KPIs, and align timelines and budgets for successful, client-focused delivery.

Overview

5
5
years of professional experience
3
3
Languages

Work History

Senior Data Manager / Project Lead

Zifo Technologies Private Limited
Chennai
10.2023 - Current
  • Engage customers, communicate timelines and estimates, ensure team productivity, handle review meetings and resolve customer issues and concerns.
  • Plan team growth, align opportunities with team members, and provide regular feedback, communication, and recognition.
  • Check and confirm proper knowledge transfer about standards and best practices are provided to team members.
  • Plan project team structure, identify risks and their mitigation strategies, review and approve validation strategies and evidences.
  • Approve validated specifications, eCRFs, and other deliverables based on quality standards prior to production deployment.
  • Implement efficient processes for continuous improvement, manage invoicing, and update monthly team forecasts.
  • Developed Study Database in Viedoc, Rave and Marvin EDCs. Have implemented Post Live Updates in Rave and Viedoc EDCs. Completed 22 projects in total.
  • Worked on manual review, medical coding, data reconciliation, protocol deviation review, sas listings.

Data Manager

Zifo RnD Solutions
Chennai
12.2021 - 09.2023
  • Execute clinical project management tasks and perform validation of study specifications, eCRFs, edit check specifications, offline SAS listings, review and approve data transfer agreements. Perform data entry and QC, data review, and query management.
  • Responsible for planning the allocations to the project members and grooming individuals in study set up activities.
  • Initiating and conduct defect analysis meetings and providing proper feedback to the project members. Identify UAT errors, conduct CAPA meetings to analyze and find the root cause and improve work quality. Highlight customer dissatisfactions to the lead, initiate necessary actions and tracking it to closure.
  • Create and update process documents and template documents based on current standards and best practices.
  • Handle offline SAS listing runs for the studies allocated on regular frequency and handling issues.
  • Attend sponsor/customer videoconference meetings as the project representative and resolve clarifications in the input documents. Providing functional and system support to sponsors and CROs as required.

Associate Data Analyst

Zifo RnD Solutions
Chennai
12.2020 - 11.2021
  • Design CDISC CDASH compliant CRF specification and edit check specification from study protocol and/or pCRFs.
  • Develop eCRF, study schedule and programme various types of validation checks.
  • Handle additional modules like reports, laboratory data import, configuration and permissions set up.
  • Creating various test case scenarios for edit checks and perform edit check QC.
  • Create validation plan and validation summary report.
  • Maintain proper documentation of study documents, ensure quality and on- time delivery.

Associate Analyst - Intern

Zifo RnD Solutions
Chennai
08.2020 - 11.2020
  • Undergo Organization specific trainings and Clinical induction trainings.
  • Have a good understanding of various stages and systems of clinical research.
  • Complete hands-on based on CDISC standards.

Education

Bachelor of Science - Physics

Sri Ramakrishna College of Arts And Science
Coimbatore, India
04.2001 -

Skills

Team leadership qualities

Time management

Project management

Critical thinking capacity

Teamwork and collaboration

Adaptability and flexibility

Accomplishments

    Webinar Series

    The various areas of clinical research where Zifo was providing services were projected to existing and new customers to improve business development between Nov 2022 to Mar 2023.

Technical skills

Clinical Systems

Marvin, Rave, Viedoc, SAS


Regulations

21 CFR Part 11, GDPR, GCL, GLP, GMP, EU ANNEX 11, HIPPA, ISO9001


Therapeutic Areas

Diabetes, Oncology, Allergy, Gastroenterology, Dentistry, Dermatology, Device, Immunology, Pulmonary/Respiratory disease, Therapy.


Tools & Terminologies

MedDRA, WHODRUG, RECIST, iRECIST, itRECIST, peRCIST

Timeline

Senior Data Manager / Project Lead

Zifo Technologies Private Limited
10.2023 - Current

Data Manager

Zifo RnD Solutions
12.2021 - 09.2023

Associate Data Analyst

Zifo RnD Solutions
12.2020 - 11.2021

Associate Analyst - Intern

Zifo RnD Solutions
08.2020 - 11.2020

Bachelor of Science - Physics

Sri Ramakrishna College of Arts And Science
04.2001 -

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Kabelan MSenior Data Manager / Project Lead