Clinical Operations Manager - Home-based
|Job Title:||Clinical Operations Manager - Home-based|
|Salary:||Excellent Pay Rates|
|Contact Name:||Steve Twinley|
|Job Published:||July 29, 2019 22:03|
If the answer to each of these questions is YES, then I would welcome hearing from you.
A highly successful Pharmaceutical organisation that exceeded all targets and revenue expectations last year. The organisation boasts a high investment ratio in drug development with a record number of products in research and clinical studies. The company is now trialing compounds in specific indication areas with a suite of clinical trials approved for phase 2 and beyond. They are headquarted in Reading, but your role will be home-based. You will encounter a range of therapeutic areas, though if you have previous experience in Oncology this will be particularly valuable to the company.
The Operations Manager is a key member of the Study Team responsible for overseeing all aspects of international operational site management. The role focuses on leading, managing and motivating globally dispersed Country Lead Monitors who provide the local interface to the CRO run investigational sites. The role encompasses training, quality oversight, identifying potential operational issues, developing study monitoring plans and coordinating investigator meetings while reviewing country study reports. Acting as the expert advisor (SME) to the study team, the job holder ensures study processes, procedures and expectations are met. While some international travel may be necessary at study launch time, ongoing travel requirements will not be extensive as the role does not involve monitoring or co-monitoring.
The studies will be predominantly phase 2 running across Europe plus possibly the US and Asia Pacific. The company will be keen on candidates who are willing to extend their contracts and manage the subsequent phase 3 study operations.
The contract is for an initial 12 months, extendable in 12-month periods. The expectation is to work with the company for the duration of the study phase as a minimum. However, they typically look to secure long-term relationships with contractors. The company is highly “contractor friendly” with a significant proportion of clinical management staff being “in-sourced colleagues” who are supported through a robust on-boarding and training program. The contract provides the security of a 2-month notice period with a competitive daily rate and flexible 7-hour working day.
As identifying the right person is of prime importance, we can cater for notice periods up to 3 months.
We are seeking experienced individuals with international / global study operational management experience in any TA (though Oncology would be preferred) with previous first-hand knowledge of site processes and monitoring gained as a CRA/SCRA. Leadership and project management abilities will be a key attribute that is required. Candidates will be considered from CRO, pharmaceutical, biotech and not-for-profit company environments.
Team fit and shared values will form an important part of the selection criteria due to the anticipated longevity of the contract (which could include permanent employment opportunities although long term contractors are equally respected).
We look forward to hearing from you and will provide full details on application.
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