Merlin Mangalath
Clinical Research Coodinator
Antwerp
Summary
Highly skilled Clinical Project Manager with a diverse background in clinical research, pharmacy, and medical underwriting.In-depth expertise in GCP, regulatory standards, and data management. Demonstrated hands-on experience managing clinical trial master files and ensuring data integrity. Proficient in statistical software and EDC systems. Strong track record of overseeing site visits and delivering comprehensive research reports. Previous roles as a Pharmacist and Medical Underwriter, coupled with a Clinical Pharmacist Residency, highlight commitment to patient safety, compliance, and effective collaboration across multidisciplinary teams.
Overview
7
7
years of professional experience
6
6
years of post-secondary education
2
2
Certifications
Work History
RESEARCH VOLUNTEER AT COMPASS PROJECT
UNIVERSITY OF ANTWERP
01.2024 - Current
- Research volunteer on the COMPASS research project, focused on improving access to the healthcare system in Antwerp
- Collaborated in the design of the research methodology
- Developed project dissemination materials
Clinical Research Coordinator
SMO CONNECT CLINICAL RESEARCH PVT LTD
01.2022 - 01.2023
- Extensive experience in GCP, regulatory standards, and data methodologies across study phases.
- Managed trial master files, ensuring data integrity. Facilitated study starts through PSSVs and SIVs.
- Oversaw site visits, monitoring, and deliverables.
- Proficient in statistical software and EDC systems (Oracle, Clindox, Castor, iMedidata) for precise data collection and analysis.
- Fostered strong relationships between sites, sponsors, and internal teams.
- Coordinated site visits and audits for quality assurance.
- Prepared detailed research reports with findings and recommendations
MEDICAL UNDERWRITER
AOSTA INDIA PVT LIMITED
01.2021 - 01.2022
- Evaluated medical records from US institutions for insurance premium assessment
- Maintained HIPPA compliance in summarizing life underwriting and disability files, summarising APS reports and evaluating diagnostic outcomes
PHARMACIST
PROMPT PHARMACEUTICALS
01.2020 - 01.2021
- Ensures accurate, safe, compatible medication dispensing and upholds pharmacy compliance with legal regulations
- Provided comprehensive patient counselling on medication administration, dosages, and potential adverse effects, promoting informed decision-making and adherence
- Efficiently addressed drug-related inquiries, delivering accurate and reliable information to clients
CLINICAL PHARMACIST RESIDENCY/INTERNSHIP
SRI RAMAKRISHNA SUPER SPECIALITY HOSPITAL
01.2018 - 01.2019
- Monitored and reported adverse drug reactions (ADRs), ensuring patient safety and compliance by closely tracking ADRs and dosage adjustments
- Conducted detailed analyses of patient safety data, implementing innovative care solutions
- Assessed patient conditions accurately, utilizing medical records and diagnostic tests for individualized treatment plans
- Participated in interdisciplinary team rounds to provide pharmacological insights and recommendations for patient care plans
Education
DOCTOR OF PHARMACY - Equivalent To Masters in Pharmacy in Belgium
DR. MGR Medical University
01.2013 - 01.2019
Skills
ICH-GCP guidelines
SOP development
Regulatory standards
Clinical research
Clinical data management
Case report forms (CRFs)
Electronic data capture (EDCs)
Study coordination
Communication skills
Interpersonal skills
Regulatory submissions
IRB approvals
Ethics committees
Informed consent procedures
Team building
Leadership
Organizational skills
Ability to work under pressure
MS Office
MS Excel
Oracle
Clindox
Castor
iMedidata
Sampling on petri plate
Gram positive testing
Gram negative testing
Certification
ICH-GCP certification from NIDA Clinical trial network, National institute of health
Languages
English
Bilingual or Proficient (C2)
Dutch
Intermediate (B1)
Timeline
RESEARCH VOLUNTEER AT COMPASS PROJECT
UNIVERSITY OF ANTWERP
01.2024 - Current
Clinical Research Coordinator
SMO CONNECT CLINICAL RESEARCH PVT LTD
01.2022 - 01.2023
MEDICAL UNDERWRITER
AOSTA INDIA PVT LIMITED
01.2021 - 01.2022
PHARMACIST
PROMPT PHARMACEUTICALS
01.2020 - 01.2021
CLINICAL PHARMACIST RESIDENCY/INTERNSHIP
SRI RAMAKRISHNA SUPER SPECIALITY HOSPITAL
01.2018 - 01.2019
DOCTOR OF PHARMACY - Equivalent To Masters in Pharmacy in Belgium
DR. MGR Medical University
01.2013 - 01.2019