Job Description

Job Responsibilities :

• Manage & coordinate in-house clinical ops
• Act as site manager and company interface for active studies
• Responsible for site regulatory document collection, filing of study documents in trial master file (TMF), ICF review/approval, IRB/EC submission (including annual submissions), payments tracking, study supply management (as appropriate), study communication, field training and support
• Responsible for implementation of clinical study documents as needed, including but not limited to: ICFs, amendments to study protocols, SOPs, Work Instructions (WIs) and study-specific forms, to ensure appropriate compliance with site start-up and initiation process and applicable regulations
• Review sample, investigator-prepared and IRB-approved informed consents
• Support the design, format and content of study guides and subject instructions
• Coordinate activities associated with site startup
• Interface with in-house data and EDC/CTMS management to ensure seamless study execution
• Support clinical dossier preparation for CEC meetings
• Support prep of clinical sites for regulatory inspections
• Partner with and work cross-functionally with various team members

Job Requirements :

• 4+ years prior experience in clinical ops role experience in Med Device or Spine industry strongly preferred
• Ability to travel for monitoring or as requested by the study team
• Strong project management skills with an entrepreneurial attitude
• Proficient with clinical trial management software including EDC, eTMF, CTMS
• Prior experience with IDE clinical trial and international regulatory process required including FDA; ICH and ISO:14155.
• Strong communication & problem-solving skills
• Self-motivated, team player, with excellent time management skills

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