Clinical Trial Manager
1 week ago
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.
- 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
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