B6 Trials Manager

Job description

Job responsibilities

PRINCIPAL ACCOUNTABILITIES

Manage and track project resource needs and contribute to contingency planning for key resources.

Create required project plans utilising appropriate planning software. Implement and monitor progress against project plans and revise as necessary.

Monitor trial/project schedule and scope to ensure both remain on track. Implement and follow pre-approved procedures for any deviations.

Oversee/complete accurate and timely Ethics/R&D Submissions in conjunction with the Lead Nurse

Serve as client/sponsor/internal stakeholders primary contact for assigned studies.

Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects.

Meet/exceed client/sponsor satisfaction expectations.

Present at external and/or internal meetings, with support from a more senior manager or Principal Investigator as needed.

Assist in ensuring that all staff allocated to assigned projects adhere to professional, SOP, and specific GCP and ICH standards.

Review proposals and budgets.

Follow defined project issue escalation process

With support from more senior management positions and the Principal Investigator, monitor and control the risk plan and provide on-going oversight to ensure mitigation plans are in place and working. Escalate risks newly identified by the project team to stakeholders.

With support from more senior management positions, meet financial performance targets for the assigned projects and proactively identify out of scope activities and execute necessary work scope change orders.

Ensure that site monitoring reports and monitoring visits are completed in a timely manner. Review monitoring reports and escalate issues.

Establish working relationships with clients/sponsors which result in client satisfaction, operational excellence and thereby increase potential for repeat business.

Contribute and participate in the delivery of presentations for new business, as required.

Ensure that internal project review meetings are conducted as needed. Depending on size and scope of project, lead meetings as appropriate.

Perform other duties as assigned by management.

Development of Case Report Formss and set up of data bases for the delivery of CRF studies such as REDCap

CLINICAL GOVERNANCE/ QUALITY

To work closely with the CRU team to deliver high quality research governance regulations including ICH-GCP

To assist the research teams including CRU/CRF and R&I with quality control and quality assurance and audit processes

Compliance with Trust, Directorate and R&D SOPs, policies and protocols

Maintenance of personal and professional development

MANAGERIAL/LEADERSHIP

To work with Information and Systems lead on the development of databases and electronic trial management systems to provide effective oversight of research delivery.

Ensure clear escalation processes and guidance is followed in reporting of all adverse events.

Exercise strong and effective leadership acting as an exemplary role model for the CRF team.

Ensure staff compliance with mandatory training and maintain current records.

Responsible for the implementation of risk management policies, including the development, implementation and monitoring of action plans to address identified risks.

To have a comprehensive knowledge of clinical research including issues on ethics, legislation management in clinical research.

Authorised signatory for department purchases through SBS

ORGANISATIONAL

Ensure appropriate allocation of study time for professional development and staff compliance with Trusts study leave policy

Provide escalation reports and study reports to the appropriate committees for review.

Attend appropriate team and departmental meetings as required such as the R&I Committee.

Person Specification

Experience

Essential

• Experience in managing or co-ordination of clinical studies
• Experience in effective use of Microsoft Office package including Microsoft Project or other planning software
• Knowledge of the principles & practice of clinical research and/or clinical trials
• Knowledge of ethical and quality standards applicable to clinical trials, including EU Directive ICH/GCP requirements
• Demonstrate knowledge of NHS Research Governance
• Understanding of the drug development process.
• Ability to understand and work with financial information.
• Working knowledge of project management processes

Desirable

• Experience of liaison with staff at all levels in the NHS, Universities and Industry
• Leadership/management experience
• Experience of being a client/sponsors primary point of contact
• Experience in Phase I Clinical Trials

Values and Behaviours

Essential

• Meticulous attention to detail and a high standard of accuracy
• Flexible approach to working hours
• Good communication skills and ability to articulate complex information
• Work well as part of a team and able to motivate and support others.

Skills and Abilities

Essential

• Good communication, presentational, training and interpersonal skills
• Ability to use a personal computer
• Skills in administration & project management
• Ability to meet tight deadlines and cope in a highly demanding environment
• Ability to work independently and prioritise/own workload and to communicate effectively with all members of the multi-disciplinary team
• Ability to liaise with clients/sponsors in a professional manner
• Good planning and organisation skills.

Desirable

• Skills in handling and management of computerised data
• Skills in developing Case Report Forms
• Skills in developing databases
• Skills in handling and management of computerised data
• Skills in the analysis and interpretation of data

Qualifications

Essential

• Graduate with Hons Degree, preferably in a science or clinical area

Desirable

• Relevant clinical research experience in a pharmaceutical company/CRO including study management and/or project management experience

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Liverpool Heart and Chest Hospital

Address

Liverpool Heart and Chest Hospital

Thomas Drive

Liverpool

Merseyside

L14 3PE

Employer's website

https://www.lhch.nhs.uk/ (Opens in a new tab)