Contract Associate Clinical Study Manager
2 weeks ago
Our client is a clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies for the treatment of cancer. Using a broad suite of proprietary and modular T cell programming technologies. The company is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognise cancer cells, break down their defence mechanisms and eliminate these cells. Our client has a pipeline of product candidates in development for the treatment of haematological malignancies and solid tumours.
Our team is passionate in the pursuit of excellence and in pushing the boundaries of cancer therapy to deliver life-changing treatments to patients. Whilst working at our client you will enjoy a flexible, diverse, and dynamic working environment which actively promotes creativity, leadership and teamwork. In addition to this our client is proud to offer a competitive salary, performance related bonus as well as private medical insurance, life assurance, pension and access to an employee share scheme. Our client promotes flexible working.
Our client is developing complex, breakthrough therapies for a globally diverse market and equally recognizes that diversity amongst our people is critical to our mission. As we draw on our differences, what we’ve experienced, and how we work, we celebrate diversity and are committed to creating an inclusive environment for all employees
As a Clinical Contracts Analyst within Global Development you will have, with support, responsibility for the clinical site and vendor contracts negotiation, review, and finalisation & lifecycle management, associated with our client sponsored clinical trials. In particular you will be responsible for the clinical contract process cycle supporting all functions within Global Development to ensure full legal and financial compliance, alignment with clinical trial budget and inspection preparedness at all times. Your day-to-day tasks will include contract negotiation, review of contracts with Legal and other functions support as required, and coordination of signatures among others. You will be a cross functional team player with the ability to influence, network and build excellent relationships while interacting with vendors, sites and the wider study teams. This is a high-profile position fundamental to ensuring our clinical trials start and complete as planned and within the forecasted annualized and lifetime budgets.
Ensure 100% Inspection readiness at all times of all Clinical Contracts by reviewing, executing, and tracking all contracts that directly support clinical trials following our clients processes and linking all contracts to their corresponding Purchase Orders.
· Negotiation, review – with Business Function, Compliance, Legal and Finance support as required - and finalization of contracts with vendors across all regions. This will include any amendments to Site contracts, Vendor contracts, consulting and committees’ agreements, and any agreement required to run and support a clinical trial that falls under the Global Development’s group managed budget.
· Review, with support, final contract package for accuracy, obtain signatures and archive as per process.
· Master university degree within clinical research, legal or financial field or
3-year university degree and 1 years’ experience of contracts management within clinical research, legal or financial environment or
At least 4 years' experience of contracts management within clinical research, legal or financial environment.
Good working knowledge of EXCEL
· Excellent organizational and project management skills
· Good working knowledge of Microsoft D365 financial platform, DocuSign, SharePoint is an advantage.
· Fluency in written and spoken English, knowledge of other languages an advantage.
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