Basilson Mathew
Clinical Data Manager
Ernakulam
Summary
Clinical data management professional with strong background in data analysis, database management, and regulatory compliance. Known for fostering effective team collaboration and delivering high-quality results amidst changing requirements. Reliable team player with focus on maximizing efficiency and driving impactful outcomes.
Overview
2
2
years of professional experience
2
2
Certifications
3
3
Languages
Work History
Junior Associate Data Manager
Pfizer
05.2023 - Current
- Have a sound knowledge of clinical trial phases, ICH guidelines, data integrity principles and good clinical practices.
- Have a brief understanding of end-to -end data management activities.
- Have a good experience and understanding of Inform applications.
- Have participated in Data management activities for Covid-19(mRNA Vaccine)-COMIRNATY.
- Intermediate level of proficiency in Microsoft Office Suite(MS Excel, MS Word, MS PowerPoint) and basic knowledge of VBA(Visual Basic for Applications).
- Experienced in performing reconciliations of external data types such as ECG, LABS, e-Diary/e-COA, etc., per Data Review Plan.
- Experienced in performing reconciliations such as IRT and SAE.
- Experienced in tools like J-Review, Spot fire, DMW.
- Experienced in discrepancy management and resolving queries.
- Experienced in P21 review.
- Have a good understanding and experience in TMF document filing.
- experienced in Coding reviews, general reviews and in performing manual reviews, finding issues and resolving the issues in timely manner.
- Have been certified as process trainer, experienced in training and mentoring new joiners.
Project
11.2021 - 06.2022
- Studied effect of different marketing strategies on marketing of cosmetic products through surveys and completed with 90 % accuracy
- Planned, designed, and scheduled phases for large projects
Intern
Drug testing laboratory
01.2021 - 02.2021
- Qualitative and Quantitative Analysis of Drugs according to SOPs and Indian Pharmacopoeia
- Knowledge in Clinical Trial and Post Marketing
- Computer literacy and ability to learn new systems.
- Good project management skills.
Education
Bachelor of Pharmacy -
Government Medical College
08.2017 - 12.2022
12th - undefined
St. Johns Vadakara
05.2014 - 05.2016
Skills
Data cleaning
Electronic data capture
Interpersonal and written communication
Team building
Clinical data management
Certification
Advance Program In Clinical Research And Management | Dec2022- Jul2023(Online)
Timeline
Junior Associate Data Manager
Pfizer
05.2023 - Current
Advance Program In Clinical Research And Management | Dec2022- Jul2023(Online)
12-2022
Project
11.2021 - 06.2022
Intern
Drug testing laboratory
01.2021 - 02.2021
Bachelor of Pharmacy -
Government Medical College
08.2017 - 12.2022
12th - undefined
St. Johns Vadakara
05.2014 - 05.2016