Either home based in the UK or office based in Reading (dependent on your location) we have a new contract opportunity to oversee the international/global clinical operations of oncology studies. Study Lead Monitors take responsibility for site management and monitoring activities while interfacing with, and overseeing, locally based Country Lead Monitors. This role does not involve monitoring and travel requirements will be minimal as you will be a key member of the Study Team. This position is due to further oncology study approval and successful phase progression. We provide a competitive daily rate, flexible 7 hour working day and the security of a 2-month notice period. This role will suit Lead CRAs looking to progress, Clinical Project Managers, Clinical Operations Managers, Lead Monitors etc.
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.
Working in 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 Monitoring and Site Management activities. The SLM works in close collaboration with the Study Manager and the Study Team for internally monitored and outsourced clinical trials. 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 while identifying potential operational issues. The scope of the role encompasses the development of Study Monitor plans, 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 their project needs.
The contract will be for an initial 12 months which will be extendable for 12-month periods usually contracted at the start of month 10 with a discretionary annual rate review. The expectation will be to work for the company for the duration of study phase as a minimum. We offer a client approved, outside of IR35 contract and a highly “contractor friendly” environment which includes structured on-boarding, training and induction processes. The company provides genuine career progression opportunities through recognition of achievement and long-term placements. The contract has the security of a 2-month notice period with a competitive daily rate and flexible 7 hour working day.
We are seeking experienced individuals with oncology study operational monitoring experience at Lead CRA, Clinical Project Manager, Operations Manager, Study Manager, Country Lead Monitor or Study Lead Monitor level. The role requires knowledge of oncology studies plus GCP, drug development processes and site management processes plus overall project management expertise. Candidates will be considered from CRO, pharmaceutical, biotech and not-for-profit company environments.
Keywords: Oncology, Lead Clinical Research Associate, LCRA, Country Study Monitor, Clinical Operations Manager, Study Operations Manager, CSM, Study Lead Monitor, Study Manager, Study Leader, Clinical Project Manager, Associate Study Leader, Associate Project Manager, Clinical Project Leader, SLM, M4 Corridor, Reading, Berkshire, Home Based
This is a contract position.