Summary
Overview
Work History
Education
Skills
Accomplishments
Personal Information
Projects
Timeline
Generic

Reeja Mol Mathew

Kerala

Summary

Organized and detail-oriented professional with over 5 years of experience in the Clinical Research Industry and in-depth knowledge of ICH-GCP. Proven leadership and interpersonal skills, fostering strong relationships with internal and external customers. High tolerance for working under pressure and consistently exceeding expectations. Skilled in management, leadership, training, and public speaking. Effective at prioritizing and planning for early delivery. Enjoys problem-solving and is technically adept in therapeutic, protocol, and monitoring knowledge. Proficient with systems and recognized for exceptional customer service and availability.

Overview

7
7
years of professional experience

Work History

Associate CRA

IQVIA
01.2023 - Current
  • Pulled and reviewed reports from eCOA and eCRF systems for dose calculations.
  • Calculated doses per protocol and compared with site calculations for compliance.
  • Followed up with Primary CRA on missing data or findings.
  • Opened and assigned monitoring follow-up items in Vault CTMS.
  • Checked and updated dose master tracker regularly.
  • Followed up on pending updates with Primary CRA.
  • Discussed issues with the functional lead and implemented mitigation plans.

Clinical Process Associate

IQVIA
09.2020 - 01.2023
  • Supported iCRA, CRAs, and RSU in updating and maintaining clinical systems for site compliance and performance
  • Assisted in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports
  • Helped with the periodic review of study files for completeness
  • Assisted in the preparation, handling, and distribution of Clinical Trial Supplies, and maintained tracking information
  • Managed tracking and flow of Case Report Forms (CRFs) and clinical data
  • Acted as a central contact for project communications and documentation
  • Accompanied CRAs on-site visits for clinical monitoring duties (post-training and approval)
  • Performed administrative tasks to support clinical trial execution.

Centralized Monitoring Coordinator

IQVIA
08.2017 - 10.2018
  • 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
  • Engaged in company training program to gain knowledge and skill required for the centralized monitoring role and mentor for the trainees
  • Presented various seminars.
  • Self-motivated, with a strong sense of personal responsibility.

Education

M Pharm -

JSS College of Pharmacy
Mysuru, India
04.2017

B Pharm -

Karpagam College of Pharmacy (MGR University)
Chennai, India
10.2014

Skills

  • Excellent knowledge in clinical trial terminology
  • ICH GCP guidelines
  • Clinical system - CTMS, EDC, IXRS, other vendor system
  • Proficient in MS Office/Office 365
  • Multi linguistic capability
  • Solid multitasking skills
  • Strong ability to communicate clearly and effectively
  • Extensive knowledge of medical terminology
  • Awareness of proper pharmaceutical storage procedures
  • FDA drug safety understanding
  • Patient counseling
  • Registered pharmacist in India
  • Positive attitude, determined, high energy, sincere
  • Good decision making and analytical skills, able to handle people in efficient way
  • Can switch to any new software within a short span

Accomplishments

  • Appreciation reward for completing the task before timeline and with minimum error
  • Coordinator for major cultural event and scientific seminars at college level
  • Anchored for several TV shows and brands like Nissan

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

Associate CRA

IQVIA
01.2023 - Current

Clinical Process Associate

IQVIA
09.2020 - 01.2023

Centralized Monitoring Coordinator

IQVIA
08.2017 - 10.2018

M Pharm -

JSS College of Pharmacy

B Pharm -

Karpagam College of Pharmacy (MGR University)

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Reeja Mol Mathew