Clinical Site Support Manager Us Based East Coast Job In Location Na

Job Description

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, listed as a public company in 2013, 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.

With our focus on neuroscience, our purpose is to advance human health by turning data into clinically valuable insights; helping our clients reduce clinical development risk and improve return on investment from their clinical development programmes. We achieve this by combining Ai machine learning imaging biomarker analysis, together with centralised neuroimaging CRO services to provide an integrated service covering every stage of clinical development through to post-marketing surveillance. We are committed to invest in continuously enhancing our validated and peer reviewed disease optimised machine learning Ai analytics services and our infrastructure and technology to support our ambitious growth strategy. Our people are empowered to enable us to achieve our company goals and their own personal development through the “4A” values at the heart of our culture: Aspiration, Ability, Agility and Accountability.

To help us deliver our medical image analysis solutions to large clinical trials we are hiring anClinical Site Support Manager (US based - East Coast)on 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 (and worldwide), 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 is responsible for performing and overseeing image quality checking (QC) and resolving site and data issues for clinical data received by IXICO in active clinical trials and research studies. The SSM role is also responsible for the successful execution and oversight of project start-up activities, including scanner qualification and site personnel training.

The role will operate autonomously for several hours a day due to its geographic location on the east coast of the US, reporting into, and working closely with the Operations team based in London, UK.

The role is home-based and will have some limited travel requirements within the US and from time to time to the UK.

Essential Duties and Responsibilities:

The duties and responsibilities listed below are representative, but not exhaustive of the role. There may be some variation and/or development of these duties and responsibilities without changing the general nature of the role:

• 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.
• 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.
• Qualitative review of images (MRI, PET, CT etc), identifying any problems which may affect subsequent quantitative analysis or radiological review.
• Performing functions in accordance with standard operating procedures (SOP) and work instructions (WI).
• Providing feedback on improvements in the image QC and site management processes, documentation, SOPs and WIs.
• Assist in developing, implementing, and ensuring compliance with policies and procedures for the Site Management and Radiology teams.
• Meeting image QC and read QC turn-around-times.
• Provide Project Managers with regular updates on image QC and data query status.
• Effectively communicate with the Science, Development, Project Start-up, and Image Analysis Teams at IXICO.
• Assist Senior Site Managers in process management (e.g., Assist with the site management communication tool / Project mailboxes / Internal support queue / Contingency uploads).
• Provide support to project management with study related activities and technical expertise, as required.
• 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 Senior Project Start-Up Manager.

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.
• This role will require collaboration between our teams in the United States and United Kingdom, as well as with Sponsors in countries worldwide. Meetings and calls may take place outside of standard work hours.
• 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.
• Ability to work independently as well as in a team matrix organization and multiple projects.
• 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.
• Opportunity to participate in the Company’s 401k savings plan.
• Opportunity to participate in the Company's sponsored health plan (ICHRA).
• Staff Annual Bonus Plans and Annual Salary Review.
• PTO Allowance in addition to all State and Federal Public Holidays.
• Life Assurance of 4x annual salary.
• Employee Benefits Portal offering various discounts in retail, food & drink, and entertainment.
• Engaging seasonal events such as Summer and Christmas parties in the UK (travel provided).
• Wellbeing initiatives such as Mental Health Awareness Training.
• Employee Assistance Programme offering advice and support on a wide range of topics.
• Fully Home-based.
• Reimbursement allowance to purchase equipment to support working from home.
• Generous employee referral scheme offering £2,000 for referring a successful candidate to the company.
• Financial assistance for professional qualifications.
• A company in an industry where your work has an impact every single day.

How to Apply

IXICO is working hard to create a representative, inclusive and empowered team, because we believe different experiences, perspectives and backgrounds make a better workplace, and ultimately better services.

IXICO doesn’t discriminate on the basis of race, colour, religion or belief, gender, national origin, age, sexual orientation, marital status, disability or any other protected class.

This is a great opportunity for a motivatedClinical Site Support Manager (US based - East Coast)in a permanent full-time capacity to thrive in an engaging and fast-paced environment, to make a difference on an everyday basis.

If you think IXICO should meet you, please send us your CV and covering letter by email to careers@ixico.com or apply directly via LinkedIn We are looking forward to your application.

Please note that IXICO will process the data provided by you only in order to perform the outlined recruitment exercise. For more details on what data we process and on what legal basis this happens please view our Recruitment Privacy Policy  or contact careers@ixico.com .