Cedent
Summary:
The Clinical Trial Manager (CTM) is responsible for managing and supporting clinical trials in compliance with applicable regulations, ICH/GCP guidelines, and standard operating procedures (SOPs). The CTM works collaboratively with cross-functional teams and partners with internal and external stakeholders to align activities with study goals and timelines.
Responsibilities:
Manage daily operations of clinical trials to ensure timely and compliant completion. Oversee tracking systems for study details, training, and trial metrics. Contribute to the development and review of study materials, such as case report forms (CRFs) and informed consent documents (ICFs). Support site feasibility, start-up, and activation processes, including document collection, ICF review, and site platform access setup. Conduct or participate in pre-study visits (PSVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs). Review monitoring visit reports for quality and completeness. Serve as the point of contact for site communications, providing updates and resolving inquiries. Attend study team meetings, preparing and distributing agendas and minutes. Set up, maintain, and perform quality reviews and final reconciliation of trial master file (TMF) documents. Assist with budget management, including review, tracking, and collaboration with clinical finance teams. Perform remote query resolution and data reviews to support clinical data management (CDM). Carry out additional duties as assigned. Requirements:
Bachelor's degree required, preferably in life sciences or a related field. At least 5 years of clinical research experience, including previous CTM experience. Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements. Experience managing global Phase 3 trials is highly preferred. Background in CNS indications, particularly Alzheimer's disease, is a plus. Strong organizational, communication (written and oral), and technical skills. Proficiency in Microsoft Office Suite, CTMS, EDC, QMS, and other relevant systems. Ability to prioritize tasks, delegate effectively, and problem-solve with sound judgment. Willingness to travel domestically and internationally, up to 15% of the time.
Department: Direct Clients This is a full time position
Responsibilities:
Manage daily operations of clinical trials to ensure timely and compliant completion. Oversee tracking systems for study details, training, and trial metrics. Contribute to the development and review of study materials, such as case report forms (CRFs) and informed consent documents (ICFs). Support site feasibility, start-up, and activation processes, including document collection, ICF review, and site platform access setup. Conduct or participate in pre-study visits (PSVs), site initiation visits (SIVs), interim monitoring visits (IMVs), and close-out visits (COVs). Review monitoring visit reports for quality and completeness. Serve as the point of contact for site communications, providing updates and resolving inquiries. Attend study team meetings, preparing and distributing agendas and minutes. Set up, maintain, and perform quality reviews and final reconciliation of trial master file (TMF) documents. Assist with budget management, including review, tracking, and collaboration with clinical finance teams. Perform remote query resolution and data reviews to support clinical data management (CDM). Carry out additional duties as assigned. Requirements:
Bachelor's degree required, preferably in life sciences or a related field. At least 5 years of clinical research experience, including previous CTM experience. Comprehensive knowledge of ICH, GCP, IRB/IEC, and local regulatory authority requirements. Experience managing global Phase 3 trials is highly preferred. Background in CNS indications, particularly Alzheimer's disease, is a plus. Strong organizational, communication (written and oral), and technical skills. Proficiency in Microsoft Office Suite, CTMS, EDC, QMS, and other relevant systems. Ability to prioritize tasks, delegate effectively, and problem-solve with sound judgment. Willingness to travel domestically and internationally, up to 15% of the time.
Department: Direct Clients This is a full time position