Clinical Trial Manager, Clinical Operations

Job title Clinical Trial Manager (CTM), Clinical Operations
Reports to Chief Development Officer (CDO)
FLSA Status Full Time (Non-Exempt)

Job Overview

Imagion Biosystems, Inc. is developing medical imaging technologies based on high sensitivity detection of magnetic nanoparticles for in vivo detection of cancer, and other human diseases. Our lead product candidate, the MagSense® HER2 imaging agent, is currently being evaluated in a Phase 1 clinical study in patients with Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer.  The study is enrolling at multiple clinical sites in Australia. The Company has additional imaging agents in preclinical development that it anticipates bringing into clinical studies in the near future.

We are looking for a highly motivated Clinical Trial Manager (CTM) who will thrive in an innovative and startup environment to join our team.  The Company is expecting this role to be a full time employment opportunity but will consider candidates for part time employment.  The primary responsibility will be to implement and manage Imagion’s current and future clinical trials in Australia as per the study protocols, GCP regulations, applicable regulatory standards and Imagion’s standard operating procedures. This position will be based in Australia and will be working remotely with up to 35% travel to clinical sites primarily on the eastern coast. The CTM will work in close collaboration with the clinical team in San Diego (USA), study CRO’s, consultants, clinical investigators and site personnel to ensure the clinical studies are executed on time and within budget while meeting the clinical development goals.

Primary Duties and Responsibilities

  • Responsible for the day-to-day operations of assigned Imagion’s clinical studies in Australia to ensure completion per established project objectives and goals in compliance with applicable GCP/ICH guidelines and other local regulatory requirements.
  • Supports all aspects of implementing and managing the clinical trials in Australia from conducting site feasibility assessments, helping with the site selection, regulatory and HREC submissions, study initiation, site training, planning, and execution, tracking enrollment, preparing for audits and study close-out.
  • Participates in meetings and liaises frequently with the broader study teams consisting of clinical operations, data management, medical monitor, clinical scientists, CROs and vendors for effective coordination of clinical study activities.
  • Reviews site monitoring reports. Conducts study monitoring and co-monitoring visits, if and when needed. Assists sites, CROs and DM functions with questions on data entry, data cleaning and query resolution.
  • Engages with the PIs and site personnel, performs site visits periodically to help identify barriers to enrollment and study workflow issues and relays the site feedback to the study team.
  • Routinely provides study progress updates, enrollment logs and dashboards to broader study team and Imagion management. Proactively apprises management of potential risks and issues that could impact deliverables and timelines. Identifies opportunities to improve study performance and resolve issues.
  • Assist in the coordination and management of Trial Master File and other study-related documentation systems and dashboards (ex. CTMS, Risk log, enrollment logs).
  • Prepares and manages timelines for study-related activities; Reviews site, CRO invoices and tracks finances against budget.
  • May have opportunity to collaborate with the study team in the creation, coordination and management of study-related documentation such as study management plans, protocols, amendments, consent forms and newsletters and recruitment material.
  • Provides general support as needed, including scheduling of team meetings, creation of meeting minutes, agendas and tracking of action items, preparing communications.

Knowledge, Experience and Skills:

  • Bachelor’s degree in biomedical or scientific disciplines, RN or equivalent experience. Advanced degree is a plus.
  • 4-5 years of clinical trial experience as a clinical trial manager, senior clinical research associate or clinical trial associate. Oncology clinical trial experience is preferred. Exposure to medical imaging trials is a plus.
  • Strong knowledge of Australian regulatory and ethical review board processes and GCP /ICH guidelines for clinical trials. Well-versed with Australian site startup and RGO processes.  Good working knowledge of drug or device development and clinical research processes.
  • Proven project management skills.
  • Strong verbal and written communication skills; operates independently and effectively in multi-study, multi-disciplinary atmosphere in a matrix environment.
  • Strong computer skills including knowledge of Microsoft Excel, Word, PowerPoint, Outlook and project planning/management tools.
  • Up to 35% travel within Australia anticipated.
  • Flexibility of working from home.
  • Legally Authorized to work in Australia.

To apply for this position, please fill out the application HERE.