Sooriya Ajithkumar
Clinical Research Professional | Data Analysis & Regulatory Compliance
Berlin, DE.About
Highly analytical Clinical Research Professional with over 3 years of experience in clinical trial coordination, data management, and regulatory compliance. Adept at applying research methodologies, conducting detailed data analysis, and preparing comprehensive reports, I am actively seeking a Research Assistant role at Hekima News. My expertise in ICH-GCP, EU CTR 536/2014, and various research tools positions me to significantly contribute to data integrity, project execution, and impactful research outcomes.
Work
Taboule catering
|Food Service Assistant at LAF (Refugee Support System)
Berlin, Berlin, Germany
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Summary
Supported operational documentation and compliance activities, maintaining audit-ready records, and coordinating stakeholder communication in a regulated environment.
Highlights
Supported operational documentation and compliance activities, ensuring strict adherence to Good Distribution Practice (GDP) and HACCP requirements.
Maintained audit-ready records, logs, and checklists, ensuring full traceability and regulatory readiness for inspections.
Coordinated internal and external stakeholder communication, streamlining document organization workflows.
Demonstrated strong organizational skills, time management, and meticulous attention to detail within a regulated environment.
MAGJ Hospital
|Clinical Research Coordinator
India, India
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Summary
Coordinated clinical trials by ensuring data integrity, regulatory compliance, and effective site communication to support research objectives.
Highlights
Performed Source Data Verification (SDV) by meticulously comparing source documents against CRF and EDC entries, ensuring 100% data integrity for clinical trials.
Managed and maintained Investigator Site File (ISF) and Trial Master File (TMF), achieving full compliance with ICH-GCP requirements and audit readiness.
Supported critical study start-up and site initiation activities, facilitating seamless project commencement and monitoring visit preparation.
Reviewed and ensured timely collection and completeness of regulatory documents, preventing delays in submission processes.
Identified, documented, and escalated protocol deviations to sponsors and regulatory bodies, mitigating risks and maintaining study compliance.
Actively communicated with investigators and site staff, resolving data queries and administrative issues efficiently to maintain study progress.
Kims health care management limited
|Clinical Pharmacist
India, India
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Summary
Ensured patient safety and clinical data accuracy through medication review, adverse event tracking, and collaborative documentation.
Highlights
Ensured patient safety by conducting GCP-aligned medication reviews and adverse event tracking, minimizing risks to participants.
Verified accurate documentation of concomitant medications, medical history, and safety data, enhancing data quality for research purposes.
Collaborated with physicians, nurses, and clinical coordinators to ensure protocol adherence and high-quality clinical documentation.
Supported clinical data accuracy and compliance with regulatory expectations, contributing to reliable research outcomes.
Thinki
|Pharmacovigilance and Clinical Research Coordinator Intern
India, India
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Summary
Processed Individual Case Safety Reports and conducted data plausibility checks, gaining foundational experience in clinical safety reporting workflows.
Highlights
Processed Individual Case Safety Reports (ICSRs) and conducted rigorous data plausibility checks, ensuring high accuracy in safety data.
Assisted with safety narrative writing, signal detection activities, and regulatory data review, contributing to comprehensive safety reports.
Gained foundational experience in AE/SAE management and clinical safety reporting workflows, enhancing understanding of pharmacovigilance processes.
Education
Berlin School of Business and Innovation
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MSc
Healthcare Management
LSSDC
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PG Diploma
Clinical Research and Pharmacovigilance
Kerala University of Health Sciences
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MPharm
Pharmacy
Kerala University of Health Sciences
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BPharm
Pharmacy
Publications
Impact of Pharmacist Integrated Care on Quality Of Life of Copd Patients - A Prospective Study
Comparative Assessment on Etiological Factors and Quality Of Life of Migraine Patients: Students Versus Others – A Prospective Study
Languages
English
German
Skills
Research & Data Analysis
Clinical Monitoring Support, Remote Site Management, Source Data Verification (SDV), Data Collection, Data Analysis, Data Interpretation, Research Methodologies, Qualitative Analysis, Quantitative Analysis, Statistical Software (SPSS, R, Python, Stata), Literature Review, Report Writing, Case Report Form (CRF) Review, Root Cause Analysis (RCA), Signal Detection, Data Plausibility Checks, Pharmacovigilance, AE/SAE Management.
Regulatory & Compliance
ICH-GCP Compliance, EU Regulation 536/2014, Risk-Based Monitoring (RBM), Regulatory Document Review, Protocol Deviation Tracking, Trial Master File (TMF), Investigator Site File (ISF), Good Distribution Practice (GDP), HACCP Requirements, Audit Readiness.
Technical Tools
Electronic Data Capture (EDC) Systems, CTMS, eTMF Platforms, Clinical Trial Documentation Systems, Microsoft Office (Word, Excel, PowerPoint), Research Management Platforms.
Communication & Collaboration
Site Communication, Stakeholder Communication, Team Collaboration, Cross-functional Collaboration, Written Communication, Verbal Communication, Presenting Findings.
Project & Operations Management
Time Management, Organizational Skills, Attention to Detail, Task Prioritization, Study Start-up Support, Site Initiation Activities, Monitoring Visit Preparation, Investigator Payments Support.
Healthcare & Medical Knowledge
Medical Terminology, Patient Safety, Medication Review, Adverse Event Reporting, Concomitant Medications, Medical History, Clinical Safety Reporting.
Projects
Pharmacoepidemiological study on the use of allopathic v/s allopathic with complementary and alternative medicines for lifestyle diseases
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Summary
A prospective pharmacoepidemiological study exploring the use of allopathic medicine alone versus in combination with complementary and alternative medicines (CAM) for lifestyle diseases. The study investigated the benefits, adverse effects, and patient demographics associated with these treatment approaches.