Head of Clinical Operations - Fixed contract
Specialist CRO based in London
Located in Central London and host to Phase I-IV clinical trials and sponsors clinical trials mainly in the areas of HIV/AIDS and Hepatitis.
This fixed^term contract (maternity cover) is responsible for ensuring that all research trials managed or sponsored are conducted in accordance with the Clinical Trials Regulations and Good Clinical Practice guidelines.
The role includes full responsibility for management of the Unit's Quality Systems, and full responsibility for the management and maintenance of all processes in relation to sponsorship of clinical trials.
A multi-faceted role with line management of the Regulatory^Compliance and Biometrics personnel, a team of approximately six personnel, that includes communication of role, responsibilities and performance expectations, conduct of regular performance reviews and provide salary increase, promotion, or adjustment recommendations.
Quality system management
Generation of maintenance of the Quality Management System (QMS)
Generation of SOPs and quality tools including implementation of standard templates
SOP management (including generation, review^distribution and training)
Facilitation of external audits including external sponsors, MHRA and FDA
Generation of the audit plan for internal trial and systems audits, management of external contract auditors.
Corrective and Preventative Action^(CAPA) generation and follow up to completion
Ongoing process improvement including review of the QMS, SOPs, and monitoring and audit procedures to ensure fit for purpose and effective.
Identification of changes in legislation or guidelines, assessment of impact on Quality Systems and the Unit's functionality, escalation to senior management / appropriate personnel
Provision of advice and input regarding clinical trial set up and compliance to collaborators / external organisations.
Identification and assessment of protocol, GCP and SOP deviations
Serious Breach identification and notification
Engagement of senior management in Regulatory Compliance requirements and importance of adherence to regulations.
Implementation and maintenance of data management and statistical SOPs
Ensuring that all data management and statistical activities are conducted in accordance with GCP and all applicable legislation.
Regulatory and Ethical
Regulatory submissions and maintenance of the approvals
Ensuring appropriate ethical and NHS R&D review of all trials, amendment submission, annual progress reporting and end of trial notifications.
Provision of 'Regulatory Green light' prior to the commencement of^a clinical trial
Contractual and third party management
Third party provider assessment and selection (including laboratory, monitors, auditors, data management providers and medical writers).Contract negotiation with sponsors, funders and other third parties
GMP and Pharmacovigilance
Set up and maintenance of pharmacovigilance systems to ensure appropriate SAE, SUSAR and annual safety reporting to regulatory authorities and ethics committees in accordance with current requirements.
Ensuring appropriate arrangements are in place to obtain required IMP safety information prior to and during the trial
Overseeing Investigational Medicinal Product management in compliance with Good Manufacturing Practice
Set up of monitoring systems and management of study monitors (internal and external)
Generation of monitoring plans and review and approval monitoring reports
Review and distribution of trial documentation
Overseeing set^up of Investigator site files and Trial Master files
Management and maintenance of archiving procedures
Keeping the Executive committee up to date with the status of all proposed studies
Liaison with external study sponsors regarding proposed trials, timelines, regulatory issues and required documentation
Attendance at pre study meetings to discuss proposed protocols
Essential Skills & Qualification
Substantial Clinical Research experience to include at least 5 years Senior Management level and line management responsibilities. This should also include management of MHRA audits, quality management systems, contract review and negotiations,
Excellent understanding of the UK Clinical trial legislation ICH, GCP, GMP
Experience of adoption of clinical trials onto NIHR portfolio and an understanding of the Human Tissue act would be advantageous.
Software Competence: MS Office, MS Project,
Valid Driving License:^Not Required
Working Language(s): English
Requirement for Business Travel: Yes minimal
Flexible Working Hours: Yes
Employment Type: Client Contract/Agency Contract
Hours: Full time