Clinical Site Lead, Medical Devices

Job Duties :

• Monitors clinical studies at sites in an assigned territory (and others as requested) to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits.
• Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects.
• Reviewing data and source documentation from investigational sites for accuracy and completeness
• Ensuring adverse events and protocol deviations are reported in an efficient manner
• Ensuring that device complaints and malfunctions are reported according to SJM Policies and Procedures
• Resolving and / or facilitating resolution of problems including identification of cause and actions to prevent reoccurrence
• Coordinates with study teams, field clinical engineers or designee and specialists.
• Enroll sites into new and ongoing clinical studies
• Facilitate enrollment of study subjects via site coordinators
• Facilitate resolution of data queries and action items at clinical sites
• Promptly reports the findings of monitoring visits according to SJM processes.
• Collaborates with in-house teams to ensure complete submission of study documents.
• Participates in conference calls and training sessions.
• Trains site personnel to ensure compliance with the study protocol and local regulations.
• Mentors less experienced clinical team members as requested.
• Demonstrates a high level of written and verbal communication skills with internal and external customers.

Requirements :

Preferred Qualifications

Term & Start