Summary
Overview
Work History
Education
Skills
SYSTEMS HANDLED
Timeline
Generic

Aneeqha

Senior Centralized Study Associate
Bengaluru,Karnataka

Summary

Dynamic Senior Centralized Study Associate ,excelling in clinical trial management. Proven ability to enhance project efficiency through effective communication and strong organizational skills. Adept at utilizing CTMS and TMF systems to ensure compliance and support study teams in achieving timely deliverables.

Overview

5
5
years of professional experience
5
5
years of post-secondary education

Work History

Senior Centralized Study Associate

Fortrea
Bengaluru
08.2023 - Current
  • Collaborating with the team to resolve study related issues. Scheduling the meetings and documenting the Meeting Minutes for Internal study team and other project review meetings. Preparation of meeting slides for sponsor call.
  • Preparing summary reports and timely updating them to provide hands-on information of SDV status and PD trends to study teams. Also support study teams in data review at various levels.
  • Assisted the Project Manager in updating of Project Plans. Updating of Task Ownership Matrix and other Project Specific Trackers. Updating of timelines in CTMS and Governance Metrics.
  • Assist in document management by timely uploading of documents to TMF, Share Point and other systems. Ensuring TMF completeness of the study at all levels and coordinating
    with the study teams to take necessary action to complete EDLs and Requiredness. Have supported during audit and have won ACE award
  • Update Risks, Issues, Decisions and Actions to Xcellerate Risk Identification and Issue Resolution (XRIM) tool; Create and follow outstanding action items to resolution.
  • Acting as backup for IN-House Monitor and Centralized Specialist
  • Assign study trainings to new team member to study and performing timely checks on the team members study specific trainings performed.
  • Performing IMP Reconciliation and Visit Letter Reconciliation.Reviewing Time Analysis Report and providing Status to PM about study team billing activities

Centralized Study Associate II

Fortrea
Bengaluru
08.2021 - 08.2023
  • Assist in updating and maintaining systems within project timelines/plans. Perform the activities as per the task list delegated by Clinical team lead and Project Manager
  • Managed Access Management for 8 studies for different sponsors. Performing access reconciliation for all the assigned studies once in quarter as per organizations SOP.
  • Exporting reports from various systems. Preparing Clean Patient Tracker and Data Metrics Reports
    Worked on "Service Now" system to manage to tickets of access request/revoke/modification.
  • Performed access management for CTMS, SharePoint, eTMF, IXRS, EDC and Other In-House systems
  • Support In-House CRA in ancillary supply management and help in preparation of site binders.

Centralized Study Associate I

Fortrea(Covance)
11.2019 - 08.2021
  • Manage clinical systems and access management to various In-House and Sponsor/Vendor users. Perform Access Reconciliation to these systems as per the Company SOP.
  • Under supervision, perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, preparing,and distributing status reports, creating and maintaining study documents etc.)
  • Worked well in a team setting, providing support and guidance.
  • Uploading documents in eTMF ( UCV and SAFE). Supported study in TMF Remediation Activity.

Education

Master of Science - Microbiology

Jain - Deemed To Be University
Bengaluru, India
07.2017 - 05.2019

Bachelor of Science - Biotechnology, Genetics And Biochemistry

Sri Bhagawan Mahaveer Jain College
Kolar, India
06.2014 - 05.2017

Skills

  • Clinical Research and Clinical Trials

  • ICH- GCP guidelines, Standard Operating
    Procedure (SOP)

  • Vendor Management

  • Strong Project Management skills

  • Microsoft Office (Excel, Outlook, Word,
    PowerPoint, OneNote Power BI)

  • Ms Excel - Pivoting, Formulas, charts, graphs and Power Query

  • Internal and External Communications

  • Time Management

  • Teamwork

  • Problem solving

  • Adaptability

SYSTEMS HANDLED

• Clinical Trial Management System( Siebel and Veeva)
• SharePoint
• eTMF (UCV- Veeva), SAFE-PAPER TMF
• EDC (Rave, Zelta- IBM and Veeva).
• IXRS (Almac, Signant Health and Suvoda)
• Central lab - Labcorp (Covance).
• Service Now

Timeline

Senior Centralized Study Associate

Fortrea
08.2023 - Current

Centralized Study Associate II

Fortrea
08.2021 - 08.2023

Centralized Study Associate I

Fortrea(Covance)
11.2019 - 08.2021

Master of Science - Microbiology

Jain - Deemed To Be University
07.2017 - 05.2019

Bachelor of Science - Biotechnology, Genetics And Biochemistry

Sri Bhagawan Mahaveer Jain College
06.2014 - 05.2017

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Aneeqha Senior Centralized Study Associate