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Barrington James
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London, Greater London
Clinical Operations Quality Lead
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Salary: Up to £100,000 per annum |
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Overview
Barrington James are fortunate enough to be partnered with an innovative US pharmaceutical company that are dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer. They are now expanding their EU team and are looking for a Sponsor Oversight lead to be home-based anywhere in the EU. This is an exciting opportunity allowing the right person to grow alongside a developing company with a fantastic pipeline. The COQL (Clin Ops Quality Lead) is responsible for assessing ClinOps performance with a focus on quality. This is through the objective of review and assessment of tasks related to inspection readiness of XXX’s clinical studies including study start-up, feasibility, pre-study site evaluation, site initiation, patient recruitment, monitoring and site close-out activities. The ideal candidate will perform both on-site and off-site reviews of study activities as defined in the Quality Oversight Plan of Clinical Operations. The COQL will/should liaise and provide feedback to the Clinical Operations, Clinical Project Management and Clinical Training teams on performance areas. This role can also serve as back-up support for other Clinical Operations tasks. Essential Duties and Responsibilities ·Assess Clinical Operations’ performance of various tasks with the focus on quality and compliance to principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines through the review and confirmation of processes and data including various report reviews, source data verification, Investigator Study File/Trial Master File review, review of protocol deviation, safety reporting management and other clinical monitoring activities ·Proactively coordinate the necessary activities required to review and assess Clinical Operations tasks related to study start-up, feasibility, pre-study site evaluation, site initiation, patient recruitment, monitoring, site close-out activities and inspection readiness of XXXs clinical studies, including liaising with various functional groups for systems access, report definition, and coordinating site visits ·Provide objective assessments and summary of performance assessments to Site Directors, Regional Directors, VPs of Clinical Operations, Chief Development Officer and other management team members, in a timely manner and as required ·Discuss and collaborate with the Clinical Operations, Clinical Project Management and Clinical Training teams on performance areas that need clarification and/or additional training ·Provide backup / support if needed for certain Clinical Operations tasks, including study start-up or monitoring tasks ·Contribute to overall Clinical Operations knowledge by sharing best practices and participating in improvement initiatives ·Contribute to the review of XXX’s systems and procedures, as needed Qualifications ·Bachelor’s Degree ·5 years of clinical trial work experience in bio-pharmaceutical/CRO ·Minimum 1 year experience in oncology ·Detailed understanding of all aspects of clinical site monitoring ·Understanding of overall global drug development required ·Experience in CTMS and eTMF systems preferred ·Thorough understanding of FDA, EMA, ICH and GCP guidelines and applicable local regulations ·Strong ability and enthusiasm to interpret study level metrics data and proactively identify and mitigate risks ·Ability to contribute to the culture of process improvement with a focus on streamlining processes adding value to the company business and needs ·Excellent written and verbal communication skills in English, as well as in applicable local language ·Must be willing and able to travel domestically and/or internationally up to 60-80% By clicking “apply” you will be sending your CV to Alex Smith at Barrington James. Alex is a Specialist Clinical Operations/Development Recruiter with a strong background in recruitment and the life science field. Alex will discuss the opportunity in detail with you, facilitate your application and will manage the process acting as a link between the company and yourself. He will assist in all elements of the process, facilitate the offer process, keep in contact throughout your notice period and even catch up with you during your first week in your new role. This opportunity has understandably been incredibly popular. We encourage all interested candidates to apply without delay as it is likely that recruitment will close prematurely. Please direct all questions (if necessary) to Alex Smith at asmithbarringtonjames alongside a copy of your CV.