Senior Clinical Trial Manager

The Royal Marsden NHS Foundation Trust; Greater London; Sur place; GBP 65 000 - 90 000; Plein temps

Résumé du poste

The Royal Marsden NHS Foundation Trust is seeking a Senior Trial Manager to lead multidisciplinary clinical trials within the Sarcoma Research Team. You will oversee trial design, regulatory compliance, site coordination and data management to ensure high-quality trial conduct and adherence to GCP.

The role requires a Life Sciences degree, GCP training, and extensive trial management experience, with strong leadership and cross-department collaboration capabilities.

Qualifications

• Significant experience in a clinical trial setting.
• Knowledge of UK Clinical Trial Regulations, GCP and regulatory framework.
• Experience in trial finances including budgeting for academic and commercial studies.

Responsabilités

• Contribute to trial design, protocol development and funding applications with CI and team.
• Prepare and continually update essential trial documentation with CI and other departments.
• Submit initial applications and amendments to sponsor committee, REC and MHRA.
• Be main contact for participating sites, assess site feasibility and coordinate site initiation visits.
• Oversee trial activity and conduct; ensure recruitment and data entry targets are met.
• Coordinate supply of trial equipment and ensure availability.
• Contribute to design and validation of the study database with statisticians/programmers.
• Maintain TMF and ISF correctly set up and maintained.
• Coordinate setup and running of oversight committees and meeting papers/minutes.
• Ensure SAE/SUSAR processes follow required timelines.
• Create and adhere to trial monitoring plans with the team.
• Plan site initiation visits and other monitoring visits as required.
• Contribute to safety reports, progress reports, manuscripts, abstracts and posters.

Connaissances

Clinical trial experience

GCP knowledge

Leadership / management

Communication skills

Microsoft Office

Formation

Life Sciences degree

GCP training

Masters degree or higher

Outils

Microsoft Office

Description du poste

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.

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.

As we often have many applicants for jobs at The Royal Marsden NHS Foundation Trust, we regret that we will only be able to contact those applicants who are short-listed for interview. Therefore if you have not heard from us within 2 weeks of the closing date, then please assume you have not been short-listed for interview on this particular occasion.

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

About us

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.

Job 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 asapplicable.
• 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 siteshave 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.

Person Specification

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
• Personnel leadership and management experience

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

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.