PREETIKA LINGSUR

Clinical Data Management Intern

SUMMARY

I am an enthusiastic biotechnology graduate with a strong foundation in Cell Biology, Microbiology, and Genetics, complemented by over two years of experience in ed-tech operations, teaching, and content creation. My goal is to apply my diverse skills and fresh perspective in a dynamic biotechnology environment while delivering exceptional results. I am committed to continuous personal and professional growth.

EXPERIENCE

Clinical Data Management Intern

Biotecnika
Bengaluru

• Gained in-depth knowledge of clinical data management (CDM) principles, processes, and regulatory guidelines.
• Assisted in understanding and supporting clinical trial phases, including preclinical, Phase I-IV, and their associated regulatory frameworks (ICH GCP, 21 CFR Part 11, GDPR).
• Acquired hands-on experience with Clinical Data Management Systems (CDMS), EDC systems, and the associated study building, data entry, and monitoring.
• Contributed to the development and customization of Case Report Forms (CRF) in compliance with CDASH and SDTM standards.
• Learned the validation and verification processes, ensuring data quality and integrity using the ALCOA+ framework.
• Gained practical knowledge in metadata management and eConsent systems for investigator and participant engagement.
• Participated in study design and management in EDC systems, including study setup, data import/export, and participant enrollment.

Academic-operation Associate

I2global Virtual Learning
Bangalore

• Analyzed customer data to identify trends and anticipate customer needs.
• Managed a diverse team of professionals, fostering an inclusive work environment that encouraged collaboration and innovation.
• Improved team collaboration by initiating regular coordination meetings.
• Increased customer satisfaction by resolving complex issues and providing exceptional service at all times.

Academic Center Head and Faculty

BYJU’S
Bangalore

• Enhanced academic performance by developing and implementing personalized learning plans for students.
• Provided personalized feedback and study strategies to help students develop independent learning skills in biology.
• Prepared lab materials, including reagents, specimens, and equipment, ensuring all resources were available and set up for seamless lab sessions.
• Contributed to program evaluation efforts, identifying areas of improvement and recommending data-driven solutions.

EDUCATION

Bachelor of Engineering: Biotechnology
The Oxford College of Engineering, Bengaluru, India

LANGUAGES

• English – Native
• Hindi – Proficient
• Kannada – Advanced

KEY ACHIEVEMENTS

• Academic Performance Enhancement: Successfully implemented a personalized learning system that greatly improved student performance.
• Cancer Research Projects: Conducted significant research on gene therapy, showcasing potential advancements in cancer treatment.

SKILLS

FDA, GCP, SQL, Clinical Data Management, ICH GCP, 21 CFR Part 11, GDPR, Data Entry, CRF

PROJECTS

TP53 Gene Activation in Cancer Cells

Mini-project on TP53 gene activation in cancer cells utilizing CRISPR Cas9 technology.

Synthesis of 1,3,4-Oxadiazole Anticancer Agent

Project focused on developing new anticancer agents with predictive molecular properties.

INTERESTS

Biotechnology and Education Enthusiast: Passionate about advancements in biotechnology and education

CERTIFICATIONS

• Intern – TP53 gene activation in cancer cells using CRISPR Cas9
• Clinical Data Management Internship from Biotecnika

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Cover Letter:

I am an enthusiastic biotechnology graduate with a strong foundation in Cell Biology, Microbiology, and Genetics, complemented by over two years of experience in ed-tech operations, teaching, and content creation. I have enhanced my skill by completing Clinical data management Training. My goal is to apply my diverse skills and fresh perspective in a dynamic biotechnology environment while delivering exceptional results. I am committed to continuous personal and professional growth.