Lakshmi Narayanan A
Cuddalore
Summary
Dynamic Clinical Research Professional with over 8.5 years of extensive experience in the clinical research sector, including 2 years as a Clinical Research Coordinator and Clinical Pharmacist at Apollo Hospitals, Chennai, and 6.5 years as an e-TMF Records Management Specialist at ICON Clinical Research. Expertise includes managing clinical trial documentation, ensuring regulatory compliance, and fostering collaboration among cross-functional teams. Possesses a robust understanding of Biotechnology, Hospital Management, Pharmaceutical Operations, and Life Sciences, along with strong knowledge of global regulatory frameworks such as ICH-GCP and 21 CFR Part 11. Proficient in Advanced Excel for effective data tracking, reporting, and analysis, with a steadfast commitment to maintaining quality, accuracy, and audit readiness throughout all phases of clinical trials.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Apollo Research and Innovations
- Managed all aspects of clinical trial activities including site initiation and closeout
- Conducted prescreening, informed consent process, enrollment, and randomization
- Handled investigational product (IP) dispensing and documentation
- Maintained source documents, CRFs/eCRFs, TMFs, and AE/SAE reporting
- Supported audits and ensured IRB/Sponsor communications
- Experienced in regulatory submissions, data validation, DCF resolution, and QA audits
- Duration: 2 years
Clinical Specialist
Triage Meditech
- Provided support in product knowledge and clinical use of devices or study drugs
- Assisted physicians and staff with technical product understanding
- Duration: 9 months
Senior TMF Specialist
ICON Clinical Research
02.2019 - Current
- Primarily handled TMF management requirements and offered insights to document creation and management.
- Streamlined document management practices include indexation and quality control by complying with regulations.
- Ensured overall TMF health is maintained and identified gaps to improve it.
- Led by example in handling process training of new recruits in classroom setup. Conducted knowledge transfer sessions to smooth the transition to live production.
- Effectively oversaw communication between cross-functional teams ensuring minimal turnaround time for query resolution and document filing.
- Maintained weekly production metrics and created reports to allow tracking, inspection and security of documents.
- Ensured to keep track of query resolution, assessing, validating and providing trend analysis on the nature.
- Proactively handled role specific tasks with continued success for smooth operation of day-to-day activities.
- Coordinated engagement events as a part of team culture development. Handled TMF filing for client and provided value in identifying filing trends.
- Ensured to run and analyze reports for TMF completeness.
- Mentored new recruits on TMF process by continuous knowledge transfer sessions.
- Coordinated communications regarding progress and completion of study documents to various functional areas.
- Effectively provided QC and audit support.
- Provided process related support for solving issues and queries.
- Coordinated engagement events as a part of team culture development.
Clinical Pharmacist Intern
Vinayaka Mission's Kirupananda Variyar Medical College and Hospital
09.2014 - 09.2015
- Participated in daily ward rounds with physicians
- Counseled patients on prescription and non-prescription medications
- Reported and monitored adverse drug reactions (ADRs)
- Provided drug and poison information
- Conducted case studies and presentations
- Performed dose adjustments, medication chart reviews, and history interviews
- Identified and monitored drug interactions
- Carried out therapeutic drug monitoring
- Preceptor: Dr. B. Arul, M. Pharm, Ph.D.
Education
Doctor of Pharmacy - Pharm D
Vinayaka Mission’s University
Salem01.2015
Higher Secondary Certificate - H.S.C
St. Joseph Higher Secondary School
Cuddalore01.2009
Secondary School Leaving Certificate - S.S.L.C
St. Antony’s High School
Aranthangi01.2007
Skills
- In-depth understanding of ICH-GCP and FDA regulations
- Knowledgeable in clinical trial phases and protocols
- Proficient in eCRFs and data entry
- Skilled in Microsoft Office suite
- Rapid learner with a focus on growth
- Effective communication skills
- Collaborative team member
Project Work
Assessment of Drug-Drug Interactions in Patients with Respiratory Diseases, Conducted in a secondary care hospital setting as part of Pharm D academic project
Extra-Curricular Activities
National Service Scheme (NSS) Member (2010–2012) Student Coordinator, National Pharmacy Week (2014), Vinayaka Mission’s College of Pharmacy
Certification
- International Conference on “Experiential Education in Pharmacy Practice” – 2011-09
- National Conference: Pharmacy Practice Module – Advanced Learning Series-4 on Infectious Diseases (2015-07)
- Participated in 4 National Level Seminars
Languages
English
Tamil
Hobbies
Reading books, Playing carrom
Clinical Trials Experience
- Ascend-D Ascend-ND Ascend-ID: Chronic Kidney Disease–Stage 4&5, Phase 3, CRC, 2017
- TDE-PH 310-311: Pulmonary Arterial Hypertension, Phase 3, CRC, 2014
- Griphon Ol: Pulmonary Arterial Hypertension, Phase 3, CRC, 2014
- Rise Study: Immuno suppression using Renal transplant patients, Phase 4, CRC, 2017
Timeline
Senior TMF Specialist
ICON Clinical Research
02.2019 - Current
Clinical Pharmacist Intern
Vinayaka Mission's Kirupananda Variyar Medical College and Hospital
09.2014 - 09.2015
Clinical Research Coordinator
Apollo Research and Innovations
Clinical Specialist
Triage Meditech
Higher Secondary Certificate - H.S.C
St. Joseph Higher Secondary School
Secondary School Leaving Certificate - S.S.L.C
St. Antony’s High School
Doctor of Pharmacy - Pharm D
Vinayaka Mission’s University