Description

You will drive clinical research initiatives and manage study lifecycles for medical device projects.

Responsibilities

• Manage and oversee clinical study operations, timelines, budgets, and resource dependencies.
• Handle reporting and communications for internal teams, clinical sites, and vendors.
• Execute study remediation and manage all aspects of study closure, including IRB/EC closure, TMF audits, closeout, archiving, and data reconciliation.
• Write clinical study reports.

Required Skills

• 6+ years of clinical research experience.
• 2+ years of medical device clinical project management experience.
• Experience leading both investigator-initiated trials and sponsor-led trials.
• Proven experience with IRB/EC closure and TMF audits.
• Proficiency in Microsoft Office applications, including Microsoft Teams.
• Experience with project management tools such as Smartsheet or Microsoft Project.
• Strong written, verbal, and interpersonal communication skills.

Key Skills

Education

Any Gradute