Following our exciting collaborations with both Merck KGaA, Darmstadt, Germany, and Novartis, and with an expanding small molecule drug discovery portfolio, Artios Pharma is recruiting for a Clinical Trial Associate. This is an excellent opportunity to join a world class research team in a dynamic, expanding Biotech company based south of Cambridge, UK. Artios is focused on identifying and developing cancer treatments by exploiting novel targets within the DNA damage response (DDR), a scientific area of high expectation following the success of PARP inhibitors in the clinic. The company is actively working on an exciting portfolio of unique DNA repair projects.
We currently have 2 clinical studies with our small molecules, ATR and Polθ inhibitors, in clinical development.
Outline of the role
We are looking for someone who will be responsible for supporting clinical studies and Clinical Development colleagues in overseeing the project management and clinical operations of clinical stage drug development projects. This will involve managing various tasks, including tracking study activities, maintaining study documentation, quality review and will include liaising with CROs and other vendors.
Responsibilities
• Liaising with clinical CROs and other vendors, ensuring that studies are managed in compliance with ICH GCP and documentation is in place to demonstrate compliance
• Managing the review of documents (such as study protocols, consent forms, contracts, and other study related documents)
• Monitoring and tracking progress of studies, including patient tracking, drug supply tracking, invoice tracking, contract approvals, insurance, site selection and set up, timelines, etc
• Review of data management aspects of clinical trials
• Assisting with the documentation of the administrative requirements for study initiation and conduct (for example: ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements
• Assisting with the planning process and participating in study start-up meetings and other activities
• Serving as resource to other team members to address any questions or clarify issues arising during the conduct of study
• Ensuring documented compliance with Artios SOPs and ICH-GCP
• Scheduling and documenting meetings, including internal and vendors
• Set up, maintenance and review of Trial Master Files (Artios and CRO)
• Participating in audits including set up, preparation and action completion
• Site visit report review and follow up
• Management of shared mailbox
Qualifications and Experience
Essential
• Degree or equivalent qualification in life sciences
• 2 plus years of clinical research experience or in a very similar role
• Understanding of clinical trial methodology
Key Skills and Abilities
Essential
• Must be very organised, enjoys working in methodical way
• Must be a ‘details’ person
• Excellent interpersonal skills as you will be dealing with CRO’s and vendors
• Ability to work independently in an organised and methodical fashion
• High level of IT literacy, including SharePoint, MS Word, Excel and PowerPoint
• Excellent communication and presentation skills
• Flexible approach to change
This is a permanent position, offering an attractive salary & benefits package.
In order to comply with UK Employment Law, all applicants must have the Right to Work in the UK or if from the EU, subject to receiving a relevant Skilled Worker Visa to work in the UK.
No agencies, thank you
If you have the right background, then please apply by sending your CV with a covering letter to hr@artiospharma.com quoting Ref 4236