Clinical Site Manager

21-11-2024
Job Type
Permanent
Emp Type
Full Time
Functional Expertise
Clinical Operations
Salary Type
Annual

Job Description

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

Consultant