Job overview

We would like to recruit a Senior Trial Manager to cover a 12-month internal secondment in this very busy research office.

Activity has been increasing following the stagnant period with pharmacy challenges and the DHR transformation programme. We now have several new complex studies early phase studies that are currently in set up and these require a senior level of study management. We will be unable to sustain current workloads without filling this vacancy. In addition, we will also be in the position of turning away innovative, high profile and revenue generating clinical trials.

Main duties of the job

The Senior Clinical Trial Manager takes overall responsibility for ensuring all clinical trials within a specified portfolio are conducted and managed in accordance with Good Clinical Practice and Trust SOPs. To provide an efficient clinical trial coordination service to the Unit head, ensuring all trials fulfil all statutory requirements. To support the Research Operations Manager and deputise where appropriate. To improve the quality of the research data across the duration of clinical trials. To be a representative for the Unit at the Trial Coordination Forum

Detailed job description and main responsibilities

To assess and evaluate the progress of on-going clinical trials and research undertaken in the unit, maintaining an accurate account of the status of the projects and to regularly update the department on the status. To assist with the organisation and implementation of clinical trials. To liaise with pharmaceutical sponsors regarding feasibility and implementation aspects of proposed clinical trials. 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 pharmaceutical sponsors. In collaboration with the clinical team to safeguard the integrity of the trial by ensuring compliance with GCP guidelines. To contribute to, monitor and review the development of clinical and research policies, procedures and audits contributing to quality assurance.

Person specification

Qualifications

Essential criteria

Life sciences (or equivalent) degree or equivalent experience Well-developed IT skills Research methods education Evidence of Continuing Professional Development.

Desirable criteria

Higher Degree qualification (e.g., MSc) Project Management qualification (e.g., PRINCE 2)

Experience

Essential criteria

Experience as a senior trial coordinator/manager (or equivalent) working in a clinical research environment. Previous clinical trial project management experience from protocol development to reporting and archiving. Detailed knowledge of clinical trials, UK Clinical trial regulations, GCP and regulatory framework. Personal and leadership management experience Experience of working across boundaries with multidisciplinary teams. Experience of preparing REC submissions Experience of developing systems and processes to allow efficient management and conduct of clinical trials. Experience in delivering teaching programmes. Experience of communicating effectively with all levels of staff - written and verbal Proven problem-solving skills.

Desirable criteria

Experience in research management, particularly Haemato-Oncology or Oncology trials Experience of Data entry & Data management

Other requirements

Essential criteria

Advanced organisational skills and ability to manage multiple projects at various stages of development & organisation Excellent crossdisciplinary/interagency communication skills and ability to facilitate collaborative working relationships Ability to appraise junior staff through performance review Confident and articulate Ability to make decisions, organise and prioritise. Ability to innovate and respond to change Able to work unsupervised Ability to work in a proactive manner to identify new risks and issues and flag upwards appropriately Maintain a positive and enthusiastic attitude towards tasks and their goals. Able to work under pressure, methodical in approach, with effective problem-solving ability Ability to work effectively to tight deadlines under direction and on own initiative. A high level of accuracy and attention to detail Ability to prioritise workload of others while balancing own workload(s) Ability to prioritise workload of others while balancing own workload(s)

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.

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.

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