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