Based in Reading, Berkshire (with scope to work from home 2 days a week) we have a new contract opportunity overseeing the international clinical operations of oncology studies. This opportunity is available due to new study funding and compound progression to further phases. We provide long term placements, a competitive daily rate, flexible 7 hour working day and the security of a 2 month notice period. To meet the needs of new studies a Clinical Operations Managers (Study Lead Monitors, however NO monitoring is involved) is required to take responsibility for site management and monitoring activities, overseeing and, interfacing with, locally based Country Lead Monitors. This role will suit Lead CRAs looking to progress, Clinical Operations Managers, Clinical Project Managers or Lead Monitors.
The company is a highly successful pharmaceutical company that exceeded all worldwide targets last year. The organisation boasts a high investment ratio in drug development with a record number of products in clinical studies. Oncology is a strategic therapeutic area where the company is boosting its pipeline in cancer research as it continues to maintain its position as a leading innovator in this field.
Working within Global Clinical Development Operations in the Oncology TA the Study Lead Monitor (SLM) is a key member of the Study Team responsible for representing and overseeing all aspects of Site Management and Monitoring activities. The SLM works in close collaboration with the Study Manager and the Study Team for trials that are outsourced to CROs. Leading, managing and motivating globally dispersed local Country Lead Monitors and CRAs, the SLM will be responsible for training and quality oversight of site management activities identifying potential operational issues. The role encompasses developing Study Monitor plans, 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 their project needs.
The contract will be for an initial 12 months and will be extendable for 12 month periods usually contracted at the start of month 10. This will include a discretionary annual rate review with the expectation to work for the company for the duration of study phase as a minimum. The client offers a highly “contractor friendly” environment with genuine career progression opportunities through recognition and long-term placements. The contract provides the security of a 2 month notice period with a competitive daily rate and a flexible 7 hour working day.
We are seeking experienced individuals with Oncology study operational management with expertise at Lead CRA, Clinical Project Manager, Clinical Operations Manager, Study Manager, Project Manager, Country Lead Monitor or Study Lead Monitor level. The role requires a knowledge of Oncology studies plus GCP, drug development processes, monitoring and site management processes. Candidates will be considered from CRO, pharmaceutical, biotech and not-for-profit company environments.
This is a contract position.