Clinical Trials Associate - (6 month FTC)

Clinical Trials Associate - (6 month FTC)

Ellipses Pharma is a global drug development company headquartered in London, focused on accelerating the development of cancer treatments through an innovative drug development model that combines unbiased vetting to de-risk initial asset selection, the expertise of a Scientific Affairs Group, which comprises more than 300 leading oncologists and an uninterrupted funding flow to minimise the time it takes to advance lead products through clinical trials and reach patients .

Reporting to the Director of Clinical Trial Delivery, the Clinical Trials Associate will support the Clinical Study Team in the efficient execution, oversight and conduct Phase I-II oncology trials.

Key Responsibilities:

• Assist in the establishment and maintenance of all project documentation including all files, records and reports according to the scope of work and SOPs
• Assist with filing and periodic review/audit/archiving of clinical study documentation (e.g., Main Study Files (TMF, MPDF, ISFs, SharePoint etc),) for accuracy and completeness in accordance with the applicable GCP guidelines
• Assist with the coordination and tracking of all information, communications, documents, materials and supplies for assigned projects
• Take and record minutes, notes and actions at assigned meetings, distribute and follow up accordingly
• Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information
• Support the preparation of presentation materials for meetings (internal/external) and project summary data. Support the coordination of project team and/or vendor meetings including logistics and materials required
• Prepare and distribute status, tracking and project finance reports, and assist the Clinical Project Manager with budget allocation and approval of invoices
• Coordinate with other Ellipses staff to identify and consolidate support processes.
• To co-ordinate ordering/dispatch and tracking of trial materials as appropriate
• To co-ordinate document translation, if required
• Serve as primary backup contact for internal Clinical Study Team members and for external stakeholders/vendors
• Will undertake project management activities as directed by the Clinical Project Manager

Experience, Skills & Knowledge

BSc in a scientific field, or previous relevant experience in a Healthcare setting

Minimum of two years’ previous experience of working in Clinical Research or the Pharmaceutical Industry as a Clinical Trials Administrator or similar role

Experience in early phase Clinical Trials in Oncology would be preferred

Ability to understand and present technical, scientific and medical information

A good understanding of the clinical trials process including the quality requirements, familiar with ICH GCP and appropriate regulations

Prior experience of TMF management

Demonstrated ability to build effective relationships with, vendors and colleagues

Microsoft Office Skills - excellent proficiency in Word, Excel, PowerPoint and Outlook required

Personal Attributes

Excellent interpersonal and communication skills, both written and verbal

An excellent grasp of numeracy and a keen eye for detail

Must be highly organised with a methodical approach to work

Self-motivated taking personal pride in delivering on personal and corporate objectives

Experience working effectively in a team/matrix environment but also able to work independently and without supervision

Pragmatic, solution focussed and willing/able to roll up sleeves in a fast-moving, small company environment

Ellipses Pharma is an organisation that values the strength of collaboration, inclusive and quick decision making, knowledge sharing and a culture built on working together on site. As a small but growing company face to face interaction is highly valued. We recognise that a more hybrid approach is at times required and we do support some element of remote working where operationally appropriate to help employees with work life integration.

By balancing in-person presence with occasional remote working, we ensure we remain agile while protecting the unique benefits that come from working side by side.

#LI-PE1