Senior Trials Manager

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Detailed job description and main responsibilities

For further information on this role, please see the attached detailed Job Description and Person Specification.
• Contribute to the RM-CTU development and strategy, including review of RM-CTU SOPs, policies and processes.
• Under the direction of the Lead Project Manager to lead implementation of systems within the Unit to ensure all Clinical Trials are conducted in accordance with all regulatory internal requirements including:
a. Medicines for Human Use (Clinical Trials) Regulations
b. Research Governance Framework for Health and Social Care
c. Human Tissue Act
d. Research and Development Policies and SOPs
• To be the main point of contact for the clinical R&D Office for set up and management of an assigned portfolio of clinical trials.
• Assist in preparation for audits and regulatory Inspections.
• To establish and maintain good channels of communication within the clinical research team, with other departments within the Trust and with other relevant organisations including non-commercial bodies and funders.

Person specification

Education/Qualifications

Essential criteria

• Masters' Degree or other higher-level degree or equivalent experience
• Recent GCP training

Experience

Essential criteria

• Demonstrable /significant experience of working in a clinical trial setting
• Detailed understanding and experience of clinical trials, UK Clinical trial regulations, GCP and regulatory framework
• Experience of trial finances including costing for academic and commercial studies

Desirable criteria

• Previous experience managing drug (CTIMP) trials
• Personnel leadership and management experience

Skills, Abilities & Knowledge

Essential criteria

• Advanced organisational skills and ability to manage multiple projects at various stages of development and organisation
• Excellent communication skills and ability to facilitate collaborative working relationships
• Able to work under pressure, methodical in approach, with effective problem-solving ability
• Competence in research orientated PC software including Microsoft Office packages

Desirable criteria

• Knowledge of principles for quality management systems
• Knowledge of budget planning and management

The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.

As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve.

Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment.

All applicants will be contacted by email to the address supplied on your application. Applicants are advised to check their email accounts regularly and to ensure that email filters are set to allow our emails.

Flu Vaccination - What We Expect of our Staff

At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease.

The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust.

Employer certification / accreditation badges

Documents to download

• Job Description (PDF, 447.8KB)
• Job Features (PDF, 128.6KB)
• Royal Marsden Trust Values (PDF, 715.5KB)
• Workplace Wellbeing and Rewards Guide (PDF, 1.2MB)