Nalina Noojet
@nalinanoojet
Clinical research professional specializing in monitoring, TMF oversight, and regulatory support.
IndiaWhat I'm looking for
I am a clinical research professional with broad experience across Clinical Operations, Monitoring, and Regulatory Support, delivering audit-ready documentation and high data integrity in global trials.
I have driven measurable improvements—reducing data discrepancies by 40%, achieving >98% data accuracy across sites, and maintaining TMF inspection readiness—by leading RBM, SDV/CRF reconciliation, protocol compliance, and CAPA implementation.
I combine scientific rigor from genomics and biotechnology with practical experience in project management, content editing, and regulatory writing to support cross-functional teams and ensure timely, compliant study delivery.
Experience
Work history, roles, and key accomplishments
Medical Content Editor
Pepper Content
Apr 2024 - Jul 2024 (3 months)
Authored and edited regulatory, clinical, and marketing documents with 100% on-time submissions, applying QC checks and fact verification to ensure accuracy and compliance with global standards.
Performed risk-based centralized and remote monitoring for global trial sites, organized investigator report reviews and KRI tracking, reducing data discrepancies by 40% and ensuring 100% sponsor audit compliance.
Clinical Research Associate
Notrox Research Private Limited
Jul 2020 - Feb 2021 (7 months)
Executed SIV, IMV, and COV across 10+ sites with >98% data accuracy through SDV and CRF reconciliation, tracked 50+ protocol deviations and implemented CAPAs that reduced recurring issues by 25%.
Project Manager
Aurigene Discovery Technologies Limited
Dec 2019 - Jul 2020 (7 months)
Managed timelines, budgets, and resources for discovery and preclinical programs, delivering progress reports and risk assessments to 20+ stakeholders and reducing project delays by 15%.
Genome Analyst
Leucine Rich Bio Pvt Ltd
Jan 2017 - Apr 2019 (2 years 3 months)
Analyzed 500+ NGS datasets to identify actionable variants, prioritized disease–phenotype correlations and validated 300+ clinically relevant variants monthly to support precision medicine initiatives.
Medical Associate Writer
Kinapse India Scientific Services Pvt Ltd
Jul 2016 - Oct 2016 (3 months)
Authored and summarized 50+ regulatory and scientific documents (CSRs, protocols, investigator brochures) with 100% on-time delivery and reduced revision cycles by 20% via QC checks.
Education
Degrees, certifications, and relevant coursework
Cliniminds (AN ISO 9001:2015 Certified Academy)
Advanced Post Graduate Diploma, Clinical Research
Grade: 75%
Advanced Post Graduate Diploma in Clinical Research and Clinical Data Management completed in January 2020 with an aggregate of 75%.
Nitte Mahalinga Adyanthaya Memorial Institute of Technology
Bachelor of Engineering, Biotechnology
Grade: 77%
Bachelor of Engineering in Biotechnology completed with an aggregate of 77% in June 2015.
RN Shetty PU College
Pre-University College, Pre-University (PCM & Biology)
Grade: 84.83%
Pre-University College completed in June 2011 with a focus on Physics, Chemistry, Mathematics and Biology and an aggregate of 84.83%.
Shri Dharmasthala Manjunatheshwara English Medium High School
SSLC, Secondary Education
Grade: 95.36%
Secondary School Leaving Certificate (SSLC) completed in May 2009 with majors in Physics, English, Kannada and Hindi and an aggregate of 95.36%.
Tech stack
Software and tools used professionally
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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