Job Title: Clinical Research Lead
Role Overview
The primary objective of the Clinical Research Lead is to oversee and execute clinical research projects. This involves taking a leadership role in interdisciplinary teams, developing project-specific documents, and preparing regulatory submissions.
1. Leading site qualification, study initiation, and study closure processes.
2. Preparing and presenting at Investigator meetings and creating study databases with data entry and routinely reviewing data/CRFs to ensure data integrity and accuracy.
3. Tracking and reporting progress of studies to internal stakeholders and developing study reports for regulatory submissions.
4. Maintaining knowledge of applicable regulatory requirements and relevant clinical literature.
Requirements
Bachelor's degree in Science or related disciplines with 5-8 years experience in medical device industry, specifically in clinical studies.