Amreen Abdul Raheman profile photo 1 on Tal

Amreen Abdul Raheman

Study support assistant

Bengaluru

3+ years of work experience

ICON plc
Jan 20251 yr 6 mosPresent

Banglore

ICON plc
Jun 20247 mosDec 2024

Bengaluru, Karnataka, India

KLE University
May 20231 yr 2 mosJun 2024

Belgaum, Karnataka, India

KLE Prabhakar Kore Hospital
May 20231 yr 1 moMay 2024

Managed site operations for Phase II–III global trials & scheduled participant visits. Participated in SIVs, monitoring visits, audits & close-out visits. Maintained Site Master File & supported regulatory document readiness. Prepared EC submissions & reviewed regulatory dossiers. Screened/recruited patients & reported SAEs via Sugam Portal. Maintained dossier logs & IP shipment documentation. Entered data in Oracle, Medidata & Veeva EDC systems. Supported trial lifecycle from start-up through close-out.

Education

KLE Academy of Higher Education and Research

Msc. Clinical research, Health/Health Care Administration/Management

KLE Academy of Higher Education and Research

20222 yrs2024
KLE Academy of Higher Education and Research

Msc in Clinical research, Health/Health Care Administration/Management

KLE Academy of Higher Education and Research

20222 yrs2024

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Amreen Abdul Raheman on Tal

Headline

Study support assistant

About

"As a Study Support Assistant at ICON plc in Bangalore, I bring a solid foundation in clinical research, backed by a master's degree from KLE University in Belgaum. My experience includes a year as a Clinical Research Coordinator (CRC), where I honed my skills in coordinating clinical trials and ensuring compliance with regulatory standards. I am passionate about contributing to impactful clinical research and am eager to continue growing in this dynamic field." I have complete knowledge about Clinical data Management START UP PHASE: •Provide Protocol Training to the below team, Protocol reviews. •Data base designing in EDC and Performing User Acceptance Testing. • Knowledge on Ecrf completion guidelines document. • Knowledge on Golive process in EDC. CONDUCT PHASE: •Performing data entry in EDC •Query Management: Open queries, closed queries, responded queries, opened queries. •Performing Data Validation, Lab reconciliation, ECG reconciliation, ST reconciliation, SAE reconciliation. Standard Backened checks and Backened checks AND Manual review. •Review of Protocol deviations. • Performing Lab ranges and units in EDC. CLOSE OUT PHASE: • Data base freeze and lock. •Archival of study.

Location

Bengaluru

Work experience

Study support assistant at ICON plc, Jan 2025 - Present · 1 yr 6 mos, Banglore

Study Start Up-Intern at ICON plc, Jun 2024 - Dec 2024 · 7 mos, Bengaluru, Karnataka, India

Clinical Research Coordinator at KLE University, May 2023 - Jun 2024 · 1 yr 2 mos, Belgaum, Karnataka, India

Clinical Research Coordinator at KLE Prabhakar Kore Hospital, May 2023 - May 2024 · 1 yr 1 mo, Managed site operations for Phase II–III global trials & scheduled participant visits. Participated in SIVs, monitoring visits, audits & close-out visits. Maintained Site Master File & supported regulatory document readiness. Prepared EC submissions & reviewed regulatory dossiers. Screened/recruited patients & reported SAEs via Sugam Portal. Maintained dossier logs & IP shipment documentation. Entered data in Oracle, Medidata & Veeva EDC systems. Supported trial lifecycle from start-up through close-out.

Education

Msc. Clinical research, Health/Health Care Administration/Management, KLE Academy of Higher Education and Research

Msc in Clinical research, Health/Health Care Administration/Management, KLE Academy of Higher Education and Research