Clinical Site Support Manager

2 weeks ago

Gisborne, New Zealand Ixico Plc Full time

Clinical Site Support Manager (US based - East Coast) Advanced analytics. Intelligent insights.
IXICO plc (AIM: IXI), is a leading neuroimaging Contract Research Organization (CRO), delivering advanced Ai analytical insights in neuroscience to the global clinical trials market. Established in 2004, IXICO has firmly established itself as a trusted partner to the global life sciences industry, supporting the development of new therapies for neurological conditions such as Alzheimer's, Parkinson's, Huntington's Disease and Multiple Sclerosis.
To help us deliver our medical image analysis solutions to large clinical trials we are hiring a Clinical Site Support Manager (US based - East Coast) in a permanent full-time capacity.
Purpose of the Role:
The holder of this position will play a significant role in support of the company's growth ambitions for the US market. Based on the east coast of the US, the incumbent will support imaging centres that are actively working on, or are being considered for, IXICO-supported trials on time-sensitive requirements, whilst collaborating and frequently interacting with UK based operations and scientific subject matter experts, including Site Management, Project Start-Up, and Biomarker Science teams.
This is a key role within the Operations Team ensuring successful delivery of IXICO's projects in the US, achieving delivery and service targets, with a focus on and delivering continuous improvement. This position interfaces with other departments within IXICO and externally with sponsors, partners, sites, and subcontractors and vendors.
The Site Support Manager (SSM) position's main responsibility is the successful execution and oversight of project start-up activities, including scanner qualification and site personnel training. The SSM role is also responsible for supporting the Site Management Team in resolving site and data issues for clinical data received by IXICO in active clinical trials and research studies.
Essential Duties and Responsibilities:
Serve as first point of contact for a portfolio of Imaging Sites on time-sensitive matters that are escalated per study-specific communications and escalation plans.
Provision of expertise for the set-up of MRI and PET imaging in clinical trials in line with regulatory requirements and support and training of clinical sites.
Support the project start-up activities on assigned projects, including site evaluation, site training, and scanning equipment set-up.
Track progress of start-up activities, including maintenance of associated records and issue escalation to the Head of Project Start-Up.
Be available to US imaging sites for real time (where possible) responses to imaging queries; document site queries in accordance with ICH/GCP.
Provide "front-line" and ongoing support for imaging related questions, upload, and technical issues.
Work with UK-based teams to resolve more complex escalated issues.
Quality control of MRI and PET test data.
Performing functions in accordance with standard operating procedures (SOP) and work instructions (WI).
Provide Project Managers with regular updates on project start-up, image QC and data query status.
Effectively communicate with the Science, Development, Site Management, Project Start-up, and Image Analysis Teams at IXICO.
Assist Senior Site Managers in process management.
Provide support to project management with study related activities and technical expertise, as required.
Qualifications and skills required for the role:
Bachelor's degree (scientific or analytic discipline) or equivalent job experience. Master's degree desirable.
Strong communication and customer service skills.
Proven independent and remote working abilities.
Demonstrated ability to present to audiences of seniority in-person and remotely.
Strong organization and time management skills and ability to effectively manage multiple competing priorities.
Good understanding of imaging modalities.
Demonstrates an excellent understanding of clinical research phases and the processes involved in the management of a clinical trial.
Strong attention to detail and ability to follow established procedures.
Highly motivated, proactive, and organised.
Proficient in the use of Microsoft Office software applications and in clinical data management systems.
How to Apply
If you think IXICO should meet you, please send us your CV and covering letter by email to ****** or apply directly via LinkedIn . We are looking forward to your application.

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