Dr. Somasundaram M
MSc Clinical Research Student At University Of Galway
Galway
Summary
A highly experienced Clinical Data Specialist with a Doctor of Pharmacy (Pharm.D) and over 2.6 years of expertise in managing and analysing clinical trial data, with a proven ability to ensure data accuracy and maintain compliance with regulatory standards. Proficient in performing data cleaning, conducting quality control checks, and resolving data discrepancies with precision. Expertise includes the development of data management plans and standard operating procedures, as well as fostering effective communication with stakeholders. Skilled in the use of Electronic Data Capture Systems and conducting various reconciliations. Currently pursuing an MSc in Clinical Research at the University of Galway, with a strong commitment to professional development, career progression, and contributing to a dynamic, growth-oriented environment.
Overview
2
2
years of professional experience
Work History
Associate clinical data coordinator
IQVIA
1 2023 - 7 2024
- Served as the primary contact for a study with over 5,000 subjects.
- Managed data cleaning processes, batch cleaning, and DMC data transfers within strict timelines.
- Prepared study metrics and status reports regularly.
- Ensured data cleaning compliance while maintaining clear communication with the project team.
- Filed documents in the TMF and conducted quarterly quality control.
- Performed reconciliations, including SAE, IRT, ECG, Q2, and COVANCE Lab, and liaised with vendors to resolve issues.
- Created and managed team and sponsor-level trackers and dashboards, such as the Study Status Dashboard.
- Developed templates for summarizing QDR and vendor issue logs across multiple studies.
- Trained CDC interns in MS Excel and RAVE, and managed query metrics.
- Therapeutic areas included Phase 3 COVID-19, thrombocytopenia disorder, arginase deficiency, schizophrenia, Phase 2 cancer, and celiac disease.
- Developed comprehensive training materials for new hires, increasing overall team proficiency
- Monitored ongoing studies closely, proactively identifying areas for improvement or increased oversight
- Liaised with IT department to address technical issues related to EDC systems, minimizing downtime during critical periods
- Facilitated clear communication between stakeholders through concise status updates and informative progress reports
Trainee clinical data coordinator
IQVIA
01.2022 - 01.2023
- Independently generated and resolved data queries to address discrepancies.
- Reviewed CRF data for completeness, accuracy, and consistency according to procedures.
- Executed freezing and locking of eCRFs within the Electronic Data Capture System.
- Established and maintained effective working relationships with stakeholders, CDL, and DMPM.
- Ensured compliance with SOPs and work instructions.
- Learned new materials, processes, and programs quickly
- Attended training courses to build understanding of processes, techniques, and industry
- Promoted positive collaboration among trainees, encouraging teamwork and problem-solving skills
- Enhanced team productivity by assisting in routine operations and shadowing experienced colleagues
Clinical Pharmacist Intern
Karpagam Faculty of Medical Sciences & Research
2 2021 - 11.2021
- Managed drug interactions by actively reporting and identifying potential interactions before medications reached patients.
- Conducted monthly prescription audits by reviewing prescriptions from various departments to ensure compliance and safety.
- Performed surgical prophylaxis audits through daily follow-ups on surgical procedures, enhancing patient safety and infection control.
- Implemented antimicrobial stewardship by monitoring patient case sheets in the ICU and other ward departments to optimise antibiotic use.
- Executed accurate dose calculations for medications, ensuring patient safety and therapeutic efficacy.
- Provided patient counselling using pamphlets and drug information leaflets, promoting informed decision-making regarding medications.
Clinical Pharmacist Intern
Fortis Hospital
12.2020 - 01.2021
- Reduced medication errors by diligently reviewing prescriptions for accuracy, drug interactions, and therapeutic duplications.
- Prepared detailed case presentations for weekly clinical rounds, fostering collaborative learning among peers and preceptors
- Conducted comprehensive medication reconciliation reviews during transitions of care to reduce risk of adverse drug events
- Increased adherence to treatment regimens by developing personalized strategies for patients struggling with complex medication schedules
- Evaluated emerging therapies as part of a multidisciplinary committee tasked with updating hospital formulary guidelines based on current evidence
- Collaborated with interdisciplinary healthcare team to optimize patient outcomes through coordinated care plans
Education
Master of Science - Clinical Research
University of Galway
Galway, Ireland 09.2024 - Current
Pharm. D -
The Tamil Nadu Dr. M.G.R. Medical University
Tamil Nadu, India 10.2015 - 2021.11
Skills
- Data Management: Proficiency in managing and analysing clinical trial data, including data cleaning, quality control, and database locking
- Regulatory Compliance: Strong understanding of regulatory requirements and ethical considerations in clinical research, ensuring adherence to guidelines and protocols
- Analytical Skills: Ability to conduct statistical analyses, interpret data, and present findings effectively, contributing to informed decision-making
- Communication Skills: Excellent written and verbal communication skills for collaborating with stakeholders, providing clear updates, and creating accessible patient information materials
- Attention to Detail: Diligence in meticulously reviewing and validating clinical trial data to minimise errors, ensure data accuracy, and uphold the integrity of the research process, particularly in data cleaning and quality control
Accomplishments
- Awarded 6 IQVIA-specific honours for contributions, particularly in DMC data transfers and database locking.
- Successfully completed 6 Interim Analyses (IA) and 4 main database locks across multiple studies.
- Acted as the point of contact for database locking in a COVID-19 clinical trial, ensuring timely and accurate completion.
- Collaborated with multiple sponsors, consistently meeting stringent timelines and delivering high-quality results.
Publications
- The Aftermath of Corona Pandemic on the Psychosocial life of Coimbatore South population: A Cross-sectional Study.
- Association of Anemia and Intestinal Worm infection among School Going Children (Short communication)
- Association of Cervical Spondylosis and Peripheral vertigo: A prospective study
Projects
Impact of Pharmaceutical Care on Patients with Type 2 Diabetes Mellitus in a Tertiary care Private Teaching Hospital
Certificate courses and training
- Online Certificate of ICH GCP from NIDA Clinical Trials network.
- Completed “Introduction to Pharmacovigilance online courses and holds a certificate of “Uppsala Monitoring Centre”
Languages
Tamil
Bilingual or Proficient (C2)
English
Advanced (C1)
Hobbies
In my free time, I enjoy playing badminton at a local club. Additionally, I occasionally indulge in painting and photography, which allow me to express my creativity and capture the beauty of the world around me. I am also passionate about learning new things and continuously expanding my knowledge and skills.
Disclaimer
The information furnished above is correct to the best of my knowledge.
Timeline
Master of Science - Clinical Research
University of Galway
09.2024 - Current
Trainee clinical data coordinator
IQVIA
01.2022 - 01.2023
Clinical Pharmacist Intern
Fortis Hospital
12.2020 - 01.2021
Pharm. D -
The Tamil Nadu Dr. M.G.R. Medical University
10.2015 - 2021.11
Associate clinical data coordinator
IQVIA
1 2023 - 7 2024
Clinical Pharmacist Intern
Karpagam Faculty of Medical Sciences & Research
2 2021 - 11.2021
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