Remote Clinical Trial Manager (CTM)

Summary

Join Apogee Therapeutics as a Clinical Trial Manager (CTM) and be accountable for the operational management and execution of global clinical trial programs (Phases II-III). The individual will oversee study scope, quality, timelines, and budget with internal functional leads, CROs, and vendors to ensure overall project objectives are met. Key responsibilities include partnering with CROs to develop robust patient enrolment strategies, managing study-related risks, developing and managing clinical trial documents, and reviewing CRO and vendor contracts.

Responsibilities

• Oversee study scope, quality, timelines, and budget with the internal functional leads, CRO and vendors to ensure overall project objectives are met
• Initiate and build strong relationships with key opinion leaders and clinical site staff
• Partner with the CRO(s) to ensure robust patient enrolment strategies are developed and effectively implemented, on time and within budget
• Partner with the CRO to ensure robust ongoing data monitoring strategies are developed and effectively implemented to ensure delivery of high-quality data
• Proactively identify and manage study related risks
• Develop and manage clinical trial documents, including but not limited to protocols, consent documents, and confidentiality agreements
• Review and manage study related plans and processes including Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, and safety monitoring
• Review CRO and vendor contracts/work orders and specifications to align with study objectives
• Work closely with Apogee CRA team in the following areas to ensure sites within respective regions are committed to quality and patients’ safety as well as meeting enrolment expectations
• Understand site issues, protocol deviations, noncompliance, and items raised in the monitoring visit reports
• 10% review of monitoring and oversight trip reports in their region
• Periodic visits to clinical sites within region for relationship building with sites
• Direct investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Oversee the TMF maintenance and ensure completeness at the end of the study
• Perform periodic QC of the TMF
• Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices
• Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
• Ensure the study is “inspection ready” always
• Oversee and coach the functional activities of Clinical Trial Associates allocated to the project