Trial Manager

Job description

Detailed job description and main responsibilities

For further information on this role, please see the attached detailed Job Description and Person 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 SUSAR reports 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

Essential criteria

• Life Sciences (or equivalent) degree or relevant experience
• Recent GCP training

Desirable criteria

• Masters' Degree or other higher-level degree

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

Desirable criteria

• Experience of trial finances including costing for academic and commercial studies
• Previous experience managing drug (CTIMP) trials

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

Other Requirements

Essential criteria

• Able to work on both sites and to be flexible to meet the needs of the role

Desirable criteria

• Willingness to travel within 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.

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. Please ensure your information is accurate to avoid errors with processing your application

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.

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