Associate Director, Field Clinical Operations

1 week ago

menlo, United States May Health Full time

Position Summary

The Associate Director, Field Clinical Operations is a hybrid position responsible for:

  • 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.
  • Coordinating with study lead and site support lead to drive site selection, enrollment, and follow-up activities.


Responsibilities

  • Lead the development and revision of Case Support training materials, tools, and processes.
  • Lead or support assigned clinical trial sites(s) during start-up, ongoing activities, close-out, and reporting.
  • Assist with the review of study-related and essential clinical study start-up documents including but not limited to Clinical Protocols, Informed Consent Form, Monitoring Plans, Case Report Forms (CRFs), and Site Training Materials.
  • Conduct or assist in site visits including Site Qualification and Site Initiation Visits.
  • 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.
  • Establish and maintain relationships with investigational study sites.
  • Train physicians on device handling, procedure completion and troubleshooting techniques related to the equipment required for the device.
  • 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.
  • Drive enrollment at US research sites and gather best practices for sharing with other research sites.
  • Train and manage other team members in case support and/or site management.


Compliance & Legal Responsibilities

  • Maintaining the highest standards of ethics in all circumstances
  • Ensuring respect of Good Clinical Practices and General Data Protection Regulation
  • Ensuring compliance with the Company quality system and all applicable guidance, standards and regulations.


Position Requirements

  • Necessary skills and experience:
  • A minimum of 15 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
  • A willingness to travel within the United States as we expect 60% travel time in this role
  • Excellent planning, organizing, problem-solving, and execution skills with the ability to appropriately initiate and escalate.
  • Proficient in site management and ability to understand and explain technical procedural and protocol requirements
  • Excellent verbal and written communication abilities, at all levels of the organization and external partners.
  • Team player with a willingness to help where needed and work with and lead a diverse team.

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