Lead CRA Opportunity in Operations Management, Home Based

This is a UK home-based opportunity, or office based in Reading (dependent on your location) and is an outstanding contract opportunity for a Lead CRA looking to take on global operational management responsibilities. As a key member of the study management team the role includes study planning and oversight / accountability for operational site activities plus liaising with locally based Country Leads. The contract is offered on an initial 12-month basis with a competitive daily rate, flexible 7 hour working day and 2-month notice period. The role is available to meet further oncology study funding and compound progression to later phases. 

The Company

The company is a highly successful and established pharmaceutical company that exceeded all worldwide targets last year. The organisation has a high investment ratio in drug development with a record number of compounds in studies. Oncology is a strategic therapeutic area and the company’s pipeline in cancer research continues to grow as it secures its position, and reputation, as a leading innovator dedicated to this field.     

The Role

Working within Global Clinical Development Operations in the Oncology TA the Study Lead Monitor (SLM) is a key member of the Study Team responsible and accountable for overseeing all aspects of Monitoring and Site Management activities. The SLM will work in close collaboration with the Study Manager and team for both internally monitored and outsourced clinical trials. Leading, managing and motivating globally dispersed Country Lead Monitors and CRAs, the SLM is responsible for training and quality oversight of site management activities while proactively identifying potential operational issues. The role encompasses the development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing Country Study Reports. Acting as the expert advisor to the Study Team the SLM will ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out. While some international travel will be necessary at study launch time ongoing travel requirements will not be extensive and will be at the discretion of the job holder to meet project needs. Please note this role does not involve monitoring or so-monitoring.           

The Contract

The contract will be for an initial 12 months with the expectation of extension which is usually confirmed at the end of the 10^th month with a discretionary rate review. We offer a competitive daily rate and the security of a 2-month notice period for both parties. The company is high “contractor friendly” with a robust on-boarding, training and induction process. The contract will be based on a flexible 7 hour per day, 35 hour per week basis.

Experience

We are seeking an experienced Study Lead level CRA or Clinical Country Lead ready to take the next step in their career. You will need specific Oncology TA experience as the studies are global and complex plus a comprehensive knowledge of GCP, drug development processes and site management processes plus drug safety requirements and data management. Candidates will be considered from CRO, not for profit or pharmaceutical company environments. 

Keywords: Senior Clinical Research Associate, Lead Clinical Research Associate, Lead CRA, SCRA, LCRA, Country Study Monitor, CSM, Study Lead Monitor, SLM, Study Manager, Study Leader, Clinical Project Manager, Clinical PM, Associate Clinical PM, Associate Clinical Project Manager, Reading, Berkshire, M4 corridor, Home Based 

This is a contract position.