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

Apogee Therapeutics is hiring a
Clinical Trial Manager (CTM)