Reeja Mol Mathew
Kochi
Summary
Client-focused and detail-oriented Clinical Research Professional with over 5 years of robust experience in clinical trial operations, TMF management, and project oversight. Proficient in implementing ICH-GCP and GDP guidelines across Phase I-III trials, this M.Pharm graduate leverages a proactive, agile approach to consistently deliver high-quality trial outcomes and exceptional client satisfaction. Adept in cross-functional collaboration, regulatory compliance, and balancing multiple priorities, they excel at streamlining processes and exceeding project milestones in fast-paced research environment
Overview
7
7
years of professional experience
Work History
Senior Clinical Process Associate
IQVIA
Kochi
01.2024 - Current
- Conduct eTMF file reviews to ensure document quality, completeness, and regulatory compliance.
Reconcile site status and track active CRAs across study sites to maintain operational oversight. - Coordinate with on-site CRAs before monitoring visits by providing action item reports, and ensuring timely follow-ups.
- Resolve project-related queries efficiently to support study teams, and maintain workflow continuity.
- Facilitate CRA access management to clinical systems, ensuring smooth site visits by providing the necessary documentation from the eTMF.
- Perform quality checks to ensure CRAs adhere to monitoring visit intervals, as per the Monitoring Plan (MP).
- Proficient in Veeva Vault eTMF, ensuring seamless document management and compliance.
In-House CRA (Eli Lilly Diabetes Trials-IQVIA Indi
IQVIA
Kochi
01.2023 - 01.2024
- Performed Dose Adjustment Reviews to ensure site adherence to the dosing algorithm outlined in the study protocol, ensuring timely completion prior to subsequent subject visits.
- Conducted Dose Adjustment Reviews utilizing programmed reports from the Clario-Studyworks portal to gain insights into enrollment, compliance, and patient safety.
- Collaborated with the functional lead to identify issues and executed mitigation strategies.
Clinical Process Associate
IQVIA
Kochi
09.2020 - 12.2022
- Generate reports and trackers to monitor study metrics, subject status, visits, and site milestones in CTMS.
Identify potential sites using the Trialforce portal. - Oversee project training, user compliance reports, and CRA monitoring plans.
- Maintain and update clinical systems while ensuring adherence to project timelines and quality standards.
- Conduct quality reviews of study files in eTMF for completeness and accuracy.
Facilitate secure document exchange between sites and sponsors via SIP.
Centralized Monitoring Coordinator
IQVIA
Bangalore
10.2017 - 08.2018
- Company Overview: Quintiles IMS (CRO)- American MNC serving the combined industries of Health, Information Technology and Clinical Research
- Experience and trained to work on CTMS, ELVIS, EDC systems like Inform, IXRS systems like Cenduit, running system reports
- Vendor access management processing of access request, service request management
- Supporting the central monitor to prepare the i-site pack and tracking site compliance
- Engage in company training program to gain knowledge and skill required for the centralized monitoring role and mentor for the trainees
- Quintiles IMS (CRO)- American MNC serving the combined industries of Health, Information Technology and Clinical Research
Education
M Pharm - Pharmacology
JSS College of Pharmacy
Mysuru, India04.2017
B Pharm -
Karpagam College of Pharmacy ( MGR University)
Chennai, India10.2014
Skills
- Clinical Systems: Veeva Vault, CTMS, SIP
- Process improvement
- Regulatory & Compliance: ICH-GCP, GDP, SOP adherence,
- Project Management: Agile prioritization, time management,
- Collaboration: Cross-functional teamwork, CRA coordination
Accomplishments
- Spotlight Award for demonstrating exceptional quality in eTMF document review, ensuring adherence to SOPs and regulatory compliance
- Awarded the Spotlight Award for efficiently coordinating and completing the Annual EDC Access Roster Review for platform users, meeting strict timelines with high quality
Personal Information
Date of Birth: 10/21/92
Projects
Therapeutic Evaluation of Herbal Medicines (Bacoside & Sitosterol) in Inflammatory and Neuropathic Pain Models in Rat
Timeline
Senior Clinical Process Associate
IQVIA
01.2024 - Current
In-House CRA (Eli Lilly Diabetes Trials-IQVIA Indi
IQVIA
01.2023 - 01.2024
Clinical Process Associate
IQVIA
09.2020 - 12.2022
Centralized Monitoring Coordinator
IQVIA
10.2017 - 08.2018
M Pharm - Pharmacology
JSS College of Pharmacy
B Pharm -
Karpagam College of Pharmacy ( MGR University)
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