Tejaswini Kondhawale

Evaluated clinical documents submitted through Veeva Vault following the eTMF index and client specifications. Escalated daily tasks with precision and attention to detail, utilizing version software and tools to streamline processes.

Triaged product complaint cases for timely reassignment through the investigational team. Executed clinical RAVE intake of product complaints into BioConnect for accurate tracking and resolution, collaborating on projects for a US multinational biopharmaceutical company.

Coordinated an AMD ophthalmology project focusing on patient outcomes, managing patient recruitment and retention strategies. Developed study protocols in alignment with regulatory guidelines, trained and supervised junior staff, and ensured data accuracy for sponsor submissions.

Coordinated clinical trial activities in compliance with regulatory standards and ICH-GCP guidelines. Managed patient recruitment, informed consent, data collection, and documentation, while facilitating communication between stakeholders and regulatory bodies.

Pursued a Bachelor of Science in Microbiology starting in 2019.

Completed training in Clinical Research, Pharmacovigilance, and Clinical Data Management starting in 2019.

Completed Higher Secondary Certificate (HSC) starting in 2016.

Completed Secondary School Certificate (SSC) starting in 2014.