The Institute of Cancer Research is looking for a Senior Clinical Trials Manager to join The Drug Development Unit (DDU) at its Sutton site in Surrey to work within the unit’s investigator-sponsored studies team.
As Senior Clinical Trial Manager (SCTM), you will work under the supervision of a CTPM and assist CTPMs for over-all oversight for trials where required and will be responsible for the day-to-day management of the trial(s) through initial feasibility, set-up, recruitment and reporting and the co-ordination of data management and biological sample management activities. You will proactively work with the trial team and will liaise effectively with Clinical Trials Programme Managers (CTPM), Statisticians, Chief Investigators and External collaborators to ensure smooth set up of trials and trial amendments. As a SCTM, you will ensure clinical studies meet the requirements of all legal and regulatory obligations and the Department of Health’s Research Governance Framework and Institutional requirements. You will be responsible for line management, training and mentoring of junior staff members and support their professional development and will contribute and provide input to CTPM towards resource and workload management within the teams.
Key Requirements
You should be a graduate in a life science or health related subject and understand Good Clinical Practice, medical terminology and clinical trial design. This post is an excellent opportunity for an enthusiastic and well-motivated person to work in the largest academic Drug Development Unit in Europe. Excellent interpersonal skills are required, as is the ability to work to high standards across a variety of tasks with constant regard to scientific and regulatory requirements. Prior demonstrable experience in oncology clinical trial management at sponsor level, working to deadlines and organising own workload, clinical trials data management experience in the planning, coordination and conduct of clinical trials at sponsor-level is essential.
For more details, please click on the link for the job description and person specification below.
Department/Directorate Information:
Drug Development Unit – Investigator Initiated Trials team.
The Drug Development Unit, led by Professor Johann de Bono aims to seamlessly integrate preclinical drug discovery, proof-of-principle phase I trials and tumour-specific evaluation of novel agents. It is a conduit for the two-way communication between laboratory and clinical teams that is so essential for successful modern drug development. The unit conducts first-in-man phase I trials involving a range of targets, including growth factor or intracellular signalling, angiogenesis, apoptosis, epigenetics and DNA repair. All trials are underpinned by extensive analysis of biomarkers, both predictive and pharmacodynamics. The DDU includes The Oak Foundation Drug Development Centre (Oak Ward) housed within The Royal Marsden at the Sutton site and specifically designed for phase I clinical trials. Opened in February 2005, the centre provides 10 inpatient beds, five treatment chairs and two outpatient suites, and allows researchers to enter almost 300 patients onto phase I trials each year. This makes the unit one of the largest of its kind in the world.
The DDU also has a portfolio of investigator-initiated phase 1 trials (IIT’s) of novel targeted agents and combinations of these, including those made available via Cancer Research-UK’s (CRUK) Experimental Cancer Medicine Centres (ECMC) Combinations Alliance. These studies are centrally managed by the IIT team within the DDU that performs those functions associated with sponsoring early phase trials including, g project management, monitoring, pharmacovigilance, database development and central data review. The successful applicant will support the Senior Clinical Data Analyst in overseeing data management activities of the IIT team.
For more information on the department of Clinical Studies or the DDU, see:
https://www.icr.ac.uk/research-and-discoveries/icr-divisions/clinical-studies/the-adult-drug-development-unit-at-the-icr-and-the-rm
https://www.royalmarsden.nhs.uk/our-research/our-research-facilities/oak-foundation-drug-development-unit
We encourage all applicants to access the job pack, linked, for more detailed information on this role. For an informal discussion regarding the role, please contact the recruiting team via Email on [email protected]
To apply for this post, please submit an online application including a supporting statement, detailing reasons why you are applying for the post and with your CV. We encourage all applicants to access the job pack attached for more detailed information regarding this role. For an informal discussion regarding the role, please contact the recruiting team by email on [email protected]
Due to the high volumes of applications we receive, we reserve the right to close the advert before the published closing date once we have received a sufficient number of applications. Therefore we advise that you to submit your application, as early as possible to avoid disappointment.