Clinical Trial Manager
Clinical Trial Manager
Posted on :
16-11-2024
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1 Vacancy
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Job Description
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 crossfunctional 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 startup and activation processes including document collection ICF review and site platform access setup.
- Conduct or participate in prestudy visits (PSVs) site initiation visits (SIVs) interim monitoring visits (IMVs) and closeout 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
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 problemsolve with sound judgment.
- Willingness to travel domestically and internationally up to 15% of the time.
Requirements Bachelor s degree in a scientific field (biology, chemistry, nursing, or pharmacy preferred). At least 12 years of experience in clinical trial management, including 8 years in a leadership role and 5 years of people management. Experience in biotech or pharma industries, particularly with autoimmune indications such as Irritable Bowel Disease or Ulcerative Colitis, preferred. Expert knowledge of FDA/EMEA regulations, ICH guidelines, and GCPs. Strong time management, organizational, and problem-solving skills. Proficiency in Microsoft Outlook, Word, PowerPoint, and Project. Demonstrated ability to manage and develop team members effectively.
Employment Type
Full Time
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