Sr. Specialist, Clinical Research

Summary :

The main function of a Sr. clinical research specialist is to perform clinical site management activities including : reviewing informed consent forms (ICFs) to ensure compliance with regulatory requirements, maintaining site essential documents in alignment with ALCOA+ standards, performing database quality checks to support data integrity, and communicating study progress and escalations. This position will also support trial master file (TMF) preparation for PMDA submission, prepare reports for Study Health meetings and Centralized Monitoring meetings, and support audit preparation activities.

Key Responsibilities :

• Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
• Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations
• Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
• Partner with cross-functional teams (e.g., clinical data management, field teams) with query management, data reviews and resolution

Additional Skills :

Education and Experience :