Renuka Rajendran
Chennai
Summary
Clinical data science lead at ICON Clinical Research focused on risk management and stakeholder collaboration to uphold compliance and achieve exceptional results. Led GSK oncology studies by effectively utilizing clinical data systems and communication strategies to improve project execution and team dynamics. Realized 95% accuracy in protocol amendment analyses, contributing to greater operational efficiency.
Overview
11
11
years of professional experience
Work History
Clinical Data Science Lead
ICON Clinical Research
Chennai
01.2015 - Current
- Acted as co-Clinical Data Science Lead (CDSL), facilitating communication between internal and external teams to streamline project execution.
- Drove risk management, analyzed protocol amendments, and oversaw trial progress to maintain study integrity and compliance.
- Led data management activities for GSK oncology studies, ensuring high-quality deliverables and compliance with regulatory standards.
Senior Clinical Data Coordinator
ICON Clinical Research
Chennai
04.2022 - 09.2025
- Directed reconciliations and protocol amendment analyses of patient profiles, ensuring compliance and accuracy.
- Guided junior team members by providing targeted training and mentorship in data review processes to enhance team capabilities.
- Received multiple recognitions for significant contributions to CRISPR and GALAPAGOS studies, highlighting expertise in clinical data management.
Clinical Data Coordinator II
ICON Clinical Research
Chennai
04.2019 - 03.2022
- Developed and validated complex data listings to enhance data integrity (Clean Patient Tracker, CRF Specifications).
- Managed reconciliation processes for clinical and third-party data, ensuring accuracy of complex eCOA reconciliations.
- Collaborated with study leads on protocol amendments and conducted impact analysis to support UAT execution.
Clinical Data Coordinator I
ICON Clinical Research
Chennai
07.2016 - 03.2019
- Reviewed clinical data for accuracy and completeness, ensuring adherence to quality standards.
- Facilitated clinical data management and EDC activities through creation and validation of specifications.
- Coordinated tasks across studies, providing regular progress updates to leads and functional management.
Assistant Clinical Data Coordinator I
ICON Clinical Research
Chennai
01.2015 - 06.2016
- Supported data review and validation activities to ensure accuracy during study start-up.
- Assisted with documentation and reconciliation processes to facilitate timely early-stage trial deliverables.
- Coordinated data collection and management for clinical research studies.
- Reviewed and verified clinical trial data for accuracy and completeness.
- Collaborated with cross-functional teams to ensure data integrity.
Education
Master of Science - Biotechnology
MES College
Aluva, KeralaSkills
- Validation and UAT
- Problem solving
- Stakeholder collaboration
- Leadership
- Communication
- Clinical data systems
- Project management
- Team leadership
- Effective collaboration
- Communication skills
Languages
- English
- Hindi
- Malayalam
- Tamil
- Telugu
Achievements And Awards
- Contributed to one of the most complex CRISPR client studies (CTX110 Phase 1/2 dose escalation study). Managed multiple PPCs and parallel data cuts under tight timelines. Awarded by Project Manager for dedication and effort.
- Earned multiple recognitions from clients and project managers for contributions to CRISPR and GALAPAGOS studies.
- Led complex reconciliations and PPCs, actively participating in protocol amendment analysis, impact discussions, and collaboration with programming and validation teams.
Therapeutic Areas
- Endocrinology
- Gastrointestinal
- Pulmonary
- Immunology
- Cardiovascular
- Oncology
Timeline
Senior Clinical Data Coordinator
ICON Clinical Research
04.2022 - 09.2025
Clinical Data Coordinator II
ICON Clinical Research
04.2019 - 03.2022
Clinical Data Coordinator I
ICON Clinical Research
07.2016 - 03.2019
Clinical Data Science Lead
ICON Clinical Research
01.2015 - Current
Assistant Clinical Data Coordinator I
ICON Clinical Research
01.2015 - 06.2016
Master of Science - Biotechnology
MES College