Sr. Clinical Operations Lead

{
  "content_hash": "748598e20af5eaa76b0a0a7aa5d7adb5309acbb01a5d089cc0cacd10e9ea0443",
  "source_hash": "d584d58c05a05e84aa95168d981a4178b10d68ca3caa660db2cf21c3ea025450",
  "last_changed_at": "2026-05-29T07:01:33.822Z",
  "active_status": "active"
}

{
  "language": "en",
  "location": {
    "raw": "Boston, Massachusetts",
    "city": "Boston",
    "region": "MA",
    "country": "United States",
    "is_remote": true,
    "confidence": 0.85
  },
  "salary_max": 143000,
  "salary_min": 86000,
  "inferred_at": "2026-06-06T07:57:11.670Z",
  "launch_scope": {
    "reason": "english_us_canada",
    "included": true,
    "language": "en",
    "location": {
      "raw": "Boston, Massachusetts",
      "city": "Boston",
      "region": "MA",
      "country": "United States",
      "is_remote": true,
      "confidence": 0.85
    },
    "countries": [
      "United States"
    ]
  },
  "remote_policy": "remote",
  "salary_period": "year",
  "workplace_type": "remote",
  "salary_currency": "USD"
}

{}

{
  "lists": [
    {
      "text": "Project Oversight",
      "content": "\n<li>Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines.</li>\n<li>Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.</li>\n<li>May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)</li>\n<li>Oversee regional startup and feasibility activities.</li>\n<li>Assist in vendor management activities as required per project.</li>\n<li>Perform review of visit reports for quality, compliance and appropriate site management.</li>\n<li>Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan.</li>\n<li>Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress.</li>\n<li>Contribute to financial project management processes as applicable.&nbsp; May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.</li>\n<li>May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;</li>\n"
    },
    {
      "text": "Project Liaison",
      "content": "\n<li>Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls&nbsp;</li>\n<li>Attend meetings with Study Sponsor to provide status updates on country and site progress</li>\n<li>Provide operational support and guidance to the monitoring team throughout project.</li>\n<li>Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documented.</li>\n<li>First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.</li>\n<li>Support line managers by providing status updates on utilization and performance of CRAs.&nbsp;</li>\n<li>Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.&nbsp;</li>\n<li>Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.</li>\n"
    },
    {
      "text": "Study Documents and Plans",
      "content": "\n<li>Develop training materials and study tools for sites and CRAs, including monitoring plans.</li>\n<li>Develop and implement enrolment and recruitment strategies together with clinical project team.</li>\n<li>Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.</li>\n\n<div>&nbsp;</div>"
    },
    {
      "text": "Qualifications ",
      "content": "\n<li>College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading</li>\n\n<div>OR</div>\n\n<li>Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training</li>\n"
    },
    {
      "text": "Other",
      "content": "\n<li>Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.</li>\n<li>Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.</li>\n<li>Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.</li>\n<li>Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.</li>\n<li>Demonstrated ability in report writing and strong ability to critically understand clinical research documents.</li>\n<li>Ability to handle multiple tasks to meet deadlines in a dynamic environment.&nbsp;</li>\n\n<div>&nbsp;</div>"
    },
    {
      "text": "Working Conditions",
      "content": "\n<li>Home-based</li>\n"
    }
  ],
  "country": "US",
  "createdAt": 1771527318377,
  "updatedAt": null,
  "categories": {
    "team": "Clinical Study Delivery - Monitoring & Site Management",
    "location": "Boston, Massachusetts",
    "commitment": "Full-time, Permanent",
    "department": "Clinical Services",
    "allLocations": [
      "Boston, Massachusetts",
      "New York, New York",
      "Newark, New Jersey",
      "Philadelphia, Pennsylvania",
      "Jacksonville, Florida",
      "Washington, DC",
      "Raleigh-Durham, North Carolina",
      "Baltimore, Maryland"
    ]
  },
  "salaryRange": {
    "max": 143000,
    "min": 86000,
    "currency": "USD",
    "interval": "per-year-salary"
  },
  "workplaceType": "remote"
}