Senior Clinical Trial Manager

Royal Marsden; Greater London; Remote; GBP 65.000 - 90.000; Vollzeit

Zusammenfassung

The Royal Marsden NHS Foundation Trust is seeking a Senior Trial Manager to lead and manage a range of clinical studies within the Sarcoma Research Team. You will collaborate with multidisciplinary staff to ensure high standards of GCP compliance and trial conduct across sites.

Role requires experience in trial management, strong communication and organisational skills, and willingness to travel as needed within the UK. This is a full-time NHS role based in London.

Qualifikationen

• Degree in Life Sciences or equivalent with recent GCP training.
• Experience in clinical trial management and knowledge of UK regulations.
• Experience managing CTIMP trials and trial finances.

Aufgaben

• Contribute to trial design, protocol development and funding applications.
• Oversee trial conduct, site feasibility, initiation visits and documentation.
• Coordinate TMF/ISF setup and ongoing maintenance.
• Prepare safety reports, progress reports, manuscripts and posters.

Kenntnisse

Organisational skills

Communication skills

Problem solving

Multitasking

Willingness to travel

Ausbildung

Life Sciences degree or equivalent

GCP training

Masters degree or higher

Tools

Microsoft Office

Jobbeschreibung

An excellent opportunity has arisen at the The Royal Marsden Hospital to work within the Sarcoma Research Team as a Senior Trial Manager.

This is a pivotal role and you will be part of a multidisciplinary team including experienced medical and nursing staff, managing an exciting range of clinical research studies.

Candidate will have prior clinical trial management experience and educated to degree level, you will work within the guidelines and policies for the conduct of clinical trials, ensuring high standards of practice in accordance with the principles of GCP.

Main duties of the job

The successful applicant should have a flexible approach to their duties and the ability to work both as part of the team as well as independently. In addition you will have excellent communication, administrative and IT skills and be supportive and open to new initiatives.

The Trust is committed to developing and delivering excellent customer focused service by treating patients, their families, friends, carers and staff with professionalism respect and dignity.

For further information please contact: Thuy-Giang Nguyen, Research Operations Manager, on 0207 811 8090 ([e-mail])

Working for our organisation

The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals – one in Chelsea, London, and one in Sutton, Surrey – as well as a Medical Daycare Unit in Kingston Hospital.

At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.

At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.

Detailed job description and main responsibilities

For further information please refer to the job description and personal specification:

• Contribute to clinical trial design, protocol development and funding applications together with Chief Investigator (CI), statistician and other members of the team.
• Preparation of and continual update of essential trial documentation in collaboration with CI, other members of the team, other departments at the Royal Marsden and other organisations as
  applicable.
• Complete and submit initial applications and amendments to internal Sponsor committee (CCR), REC and MHRA and other organisations as required for the clinical trial.
• To be the main point of contact for participating sites in multi centre studies ensuring appropriate assessment of site feasibility for trial participation, planning site initiation visits and ensure sites
  have all applicable documentation in place.
• To have oversight of clinical trial activity and conduct of designated clinical trials.
• Manage systems for tracking trial conduct, such as ensuring recruitment and data entry targets are met and checking stock of IMP at sites.
• Coordinate supply and provision of any clinical trial equipment or supplies and ensure these are available as required.
• Contribute to design and validation of the database for each study, working with the statisticians and programmers.
• Ensure that Trial Master File (TMF) and Investigator Site Files (ISF) are correctly set-up and maintained.
• Coordinate set-up and running of trial oversight committees and regular meetings to plan and manage the studies, including preparing the agenda and meeting papers and writing minutes.
• Ensure that processes for receiving and processing Serious Adverse Event (SAE) and SUSARreports are correctly followed to the required timelines.
• Ensure trial specific monitoring plans are created and adhered to, working with the statisticians and monitoring team.
• Plan and perform site initiation visits, and other monitoring visits as required.
• Contribute to preparation and submission of safety reports, progress reports, manuscripts, abstracts and posters.

Education / Qualifications

• Life Sciences (or equivalent) degree or relevant experience
• Recent GCP training
• Masters’ Degree or other higher-level degree

Experience

• 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
• Previous experience managing drug (CTIMP) trials

Skills, Abilities & Knowledge

• 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
• Able to work on both sites and to be flexible to meet the needs of the role
• Knowledge of principles for quality management systems
• Knowledge of budget planning and management
• Willingness to travel within the UK and occasionally overseas to attend meetings and conferences

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.

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.