Clinical Trial Manager

2 weeks ago

San Diego, United States Cedent Consulting Inc Full time

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.

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