Job Description

About the Company:

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Re: Cognition Health is a leading provider of clinical services specializing in cognitive impairment. We deliver expert clinical care to private patients and are one of the foremost providers of clinical trials in the world and deliver award winning medico-legal services. We value people who are dedicated, hardworking and looking to contribute to the growth of the business at an exciting time.


The successful applicant will have access to all Re: Cognition Health's benefits. On top of this the successful candidate will have the opportunity to work in one of our established clinics around the country.

The Clinical Trials Manager Role:

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The Clinical Trials Manager role you will be responsible for the set up and delivery of all clinical trials according to RCH governance, operational, financial and developmental strategies and in compliance with Good Clinic Practice (GCP) principles, assistance in the preparation for any Sponsor, CRO and regulatory audits and inspections and overall the management of the clinical trials' operational aspect including clinical trials participants and any external vendors.

Clinical Trials Manager Responsibilities:

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Liaison with clinicians and Clinical Trials Site Operations Managers, to ensure the Principal Investigator(s) maintain full oversight of all trial participants and trial quality. Lead by example, by supporting the coordination of UK trials to the highest standard, providing mentoring and support to more junior staff. Support the site PI(s), Clinical Trials Managers, and Study Coordinators in ensuring that all members of each clinical trials team working on the clinical trial portfolio, are trained and compliant prior to clinical trial delegation, and ensuring individuals take responsibility for maintaining their training. Work collaboratively with the PI and Sub-I(s), Clinical Trials Site Operations Managers, patient recruitment staff and senior management to achieve the sites key clinical trial KPIs, including screening, randomization and trial quality standards. Work collaboratively with the PIs and Clinical Trials Site Operations Managers, to ensure that the UK onsite trials team members understand and appreciate their site's targets and results, across the clinical trial portfolio at the site, on a weekly, monthly and annual basis. Support with the development and implementation of prescreening tools and strategies for potential participants, for recruiting studies Lead by example and promote the completion of all activities at UK sites, with regards to Good Clinical Practice and IATA compliance, reporting deviations and concerns to your manager immediately. Ensure that all clinical trials staff at the site are always 100% up to date with SOP and compliance (mandatory online) training. Accountable for ICH-GCP compliance across all assigned studies To ensure that the highest levels of customer/patient care and clinical delivery are maintained at all times To support the development of the business by working closely with clinicians and consultants to maximise business opportunities and recruit patients Adhere to the organisation's policies and SOPs and ensure all members of the clinical trials team are trained and compliant To ensure that all administration is performed accurately and in a timely way including the entry of patient records on all necessary databases and forms To ensure that all patient records are accurate, stored appropriately and all confidential information is retained in accordance with data protection requirements To ensure that the Centre is maintained and presented to the highest standards as expected by The organisation and that all equipment is calibrated and maintained in line with best practice To ensure adequate stock within the Centre ensuring that it is ordered in a timely way and that stock is controlled Work collaboratively with the PIs and Clinical Trials Site Operations Managers, to ensure that accurate and timely entry of data into the relevant EDC system(s) and resolution of data queries within sponsor regulated timeframe, ensuring the highest quality is achieved for data collection and data entry for each trial. Work collaboratively with the Director of Clinical Operations and the Clinical Trials Site Operations Managers, to ensure that the UK clinical trials teams are trained and coherent with document management processes, and the critical maintenance and management of the trial Investigator Site Files To seek feedback from patients as to their experience and record these findings and analyse them to support the ongoing development of the service To perform internal audits of working practices within the Centre to measure compliance against company SOPs and GCP as and when required

Clinical Trials Manager Requirements:

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Essential:

Life sciences degree or similar with min 2:1 + At least 3-year experience within clinical trials research + Proficiency in the use of Microsoft Office packages (Word, Excel, PowerPoint)
+ Experience with electronic data capture (EDC) systems

Desirable:

Ideally experiences with cognitive clinical trials

Clinical Trials Manager Benefits:

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Continuous professional development 25 -30 Days Annual Leave + Bank Holidays Private Health Insurance Life insurance Employee Assistance Program Pension Scheme Perkbox Free Mortgage Advisor Scheme Electric Vehicle Scheme

Salary: 37,000 + depending on experience

If you think that you are suitable for this Clinical Trials Manager role, please apply now!