Job Description 400+. The number of dedicated and inspired professionals in the US Trial Monitoring Organization (TMO) function who are empowered to ask new questions and make bold decisions to bring lifesaving medicines and treatments to patients. Come join our curious and unbossed team and make an impact on patient’s lives every day!
Collaborating with the Clinical Study Manager, the Field Team, and the Global team, the Site Support Lead will be responsible for driving study start-up and delivering on US site activation milestones. In this role, you will ensure consistent and accurate country study start-up planning and tracking, time-line optimization, risk mitigation actions, and act as the point of reference for US study start-up intelligence (for example local regulations/requirements, timelines, metrics, and best practices).
Your responsibilities will include, but are not limited to:
• Drive site activation activities for the US in collaboration with partners, per above. Develop a detailed study start-up and site activation plan including timelines and potential risks with planned mitigations. Drive proactive risk mitigation, effective startup scenario generation and planning through data driven analysis.
• Drive local Full Protocol Package process by obtaining documentation for the country for Health Authority (HA) and/or Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) submissions; obtain global documents for site activation from the Global Study Start-Up Lead or equivalent.
• Create and manage the US-Customized Informed Consent Forms (ICFs) template utilizing using the global ICF(s) for the study. Review and negotiate site ICF pre-IRB submission, post-IRB approval, and amended ICFs during study start up. Drive IRB submission/approval process, coordinating timely answers to EC/IRB questions.
• Drive preparation, filing, and quality check verification of start-up documents, including Country and site TMF.
• Work with Contracts & Payments team to drive Investigator/site contracts negotiation and execution during study start up. Drive completion of Ready to Initiate Site (RIS) process, including requesting and confirming access to study systems (i.e.: IRT, eCRF, Central Lab, etc.).
• Lead study start-up meetings with CRAs, CRA Managers, and CSM, coordinating Site Initiation planning. Track landmarks and analyses study start-up data (metrics) to ensure efficiency, to reduce start-up timelines, and create improvements. Ensure update of accurate and complete US start-up data within company systems (e.g., IMPACT).
• Contribute to SSU lessons learned and identify trends and opportunities for start-up activities optimization and efficiency improvement.
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectations of working hours and travel (domestic and/or international) will be defined by the Hiring Manager.