Director of Clinical Operations

RESPONSIBILITIES

  • Provide project management and program oversight to plan and manage clinical trials in accordance with regulations
  • Responsible for the high quality conduct of all DotLab clinical trials
  • Collaborate with advisors, PIs, statisticians, regulatory consultants, and DotLab leadership to develop robust clinical trial protocols
  • Facilitate all study startup activities, including identifying, qualifying, and auditing clinical trial sites and ensuring they are properly trained to comply with clinical study protocols and SOPs
  • Develop required clinical study documentation in accordance with regulations (e.g., to seek IRB approvals, patient consent forms) 
  • Oversee and drive patient recruitment across study sites, including implementing recruitment programs as needed
  • Proactively monitor trials by arranging regular site visits, ensuring compliance, and ensuring appropriate data collection
  • Provide regular updates to key stakeholders regarding study progress (e.g., leadership, PIs, site staff) via formal and informal written communications and meetings
  • Prepare and manage study budgets, negotiate budget agreements with trial sites, and oversee trial spending
  • Oversee trial data management, including development of case report forms, managing EDC systems, developing data QC protocols, collecting required source documentation, and ensuring all queries have been closed prior to study completion

REQUIREMENTS

  • Excellent project management skills, with an ability to manage multiple priorities, timelines, resources, and stakeholders
  • Deep experience working with CROs
  • Ability to work independently
  • Ability to think strategically about clinical development requirements but also execute day-to-day activities

TRAVEL

  • As needed for site visits

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