Clinical Operations Manager - Home-based

Clinical Operations Manager - Home-based

Job Title: Clinical Operations Manager - Home-based
Contract Type: Contract
Location: Reading
Salary: Excellent Pay Rates
Start Date: 2019-07-28
Reference: J16269
Contact Name: Steve Twinley
Contact Email:
Job Published: July 29, 2019 22:03

Job Description

Are you seeking a home-based contract in the UK with flexible working hours? Are you a Clinical Operations Manager / Lead with extensive international clinical trial, leadership and project management experience? Are you looking to form a long-term relationship with an organisation that engages contractors in strategic roles?
If the answer to each of these questions is YES, then I would welcome hearing from you.
The Company
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 Role
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
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.