Igna Thankachan
@ignathankachan
Highly skilled Clinical Research Professional with extensive trial coordination experience.
What I'm looking for
I am a Clinical Research Professional with over 2 years of experience in coordinating clinical trials and managing regulatory submissions. My expertise lies in ensuring data integrity and compliance within both hospital and pharmaceutical settings. I have a proven ability to oversee essential document processes and manage safety data, collaborating effectively with multidisciplinary teams to ensure efficient study conduct.
Throughout my career, I have demonstrated strong adherence to ICH-GCP guidelines and regulatory requirements. My role as a Drug Safety Associate at IQVIA involved processing high volumes of Individual Case Safety Reports (ICSRs) and conducting aggregate safety reviews, ensuring 100 percent compliance with regulatory timelines. I have also contributed to the management of Trial Master Files (TMFs) and supported regulatory inspections, showcasing my commitment to maintaining audit-ready documentation.
In addition to my professional experience, I have published research on medication reconciliation in oncology and cardiology, further solidifying my knowledge in the field. I hold a Master of Pharmacy and am a Certified Clinical Research Professional (CCRP), expected to be certified by 2025. I am passionate about advancing clinical research and contributing to innovative healthcare solutions.
Experience
Work history, roles, and key accomplishments
Drug Safety Associate
IQVIA
Mar 2023 - May 2024 (1 year 2 months)
Processed high volumes of Individual Case Safety Reports (ICSRs) for oncology, cardiovascular, and vaccine studies, ensuring 100 percent compliance with regulatory timelines. Managed Trial Master Files (TMFs) in Veeva Vault and supported regulatory inspections, demonstrating strong adherence to compliance standards.
Drug Safety Associate
Bioclinica
Mar 2021 - Jun 2022 (1 year 3 months)
Drafted Confidentiality Disclosure Agreements (CDAs) and Clinical Trial Agreements (CTAs), supporting contract negotiation processes. Managed site-qualification visits and submitted Research Ethics Board (REB) applications, ensuring regulatory compliance for study initiation.
Education
Degrees, certifications, and relevant coursework
St. James College of Pharmaceutical Sciences
Master of Pharmacy, Pharmacy
Completed a Master of Pharmacy degree, focusing on advanced pharmaceutical sciences. Gained in-depth knowledge and practical skills relevant to the field.
St. James College of Pharmaceutical Sciences
Bachelor of Pharmacy, Pharmacy
Obtained a Bachelor of Pharmacy degree, building a foundational understanding of pharmaceutical principles and practices. Developed essential skills for a career in pharmacy.
Availability
Location
Authorized to work in
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