Senior Clinical Site Manager

Summary:

leading, assisting, and providing site management support for clinical sites during study start-up, enrollment, maintenance, and close-out. leading and providing technical case support and physician training within an investigational medical device clinical trial.

Requirements:

• A willingness to travel within the United States.
• Excellent planning, organizing, problem-solving, and execution skills with the ability to appropriately initiate and escalate.
• Team player with a willingness to help where needed and work with a diverse team
• A minimum of 8 years of relevant industry or clinical experience from industry-related positions that support clinical development and clinical case support of therapeutic and/or implantable devices
• Surgical or operating room experience (MUST)
• Women’s health experience or past experience of working on reproductive studies.

Responsibilities:

• Train study site personnel to study conduct, protocol, and database.
• Identify and escalate site issues and challenges to the study team; propose and implement solutions to prevent issues from occurring again and ensure inspection readiness.
• Provide on-site, real-time guidance during clinical cases and proactively prepare contingency plans to address unforeseen occurrences
• Document procedural case observations for regulatory requirements and ongoing continuous improvement
• Collaborative mindset in providing feedback to cross-functional teams to support the study, device and future commercialization