Senior Data Manager / Clinical Trials Associate

Job overview

The NIHR UCLH Clinical Research Facility (CRF) is a well-established research facility operating across two specialist sites within University College London Hospitals NHS Foundation Trust. The Leonard Wolfson Experimental Neurology Centre at Queen Square specialises in neuroscience experimental medicine, while the Bloomsbury CRF at Tottenham Court Road delivers cancer and medical research studies.

We are seeking a motivated and enthusiastic Senior Data Manager to join our dynamic CRF team. The successful candidate will line manage half the CRF data management team while overseeing clinical trial data management across a diverse portfolio of studies, ranging from first-in-human and experimental medicine studies to complex Phase III clinical trials and non-IMP research.

The post holder will ensure high-quality clinical data management in line with study protocols, Good Clinical Practice (GCP), and UK Medicines for Human Use (Clinical Trials) Regulations. They will also support the Quality Assurance and Governance Manager in maintaining data quality, integrity, and regulatory compliance across the CRF.

We are looking for someone with: •    Excellent communication and organisational skills  •    Strong leadership and team working skills  •    Exceptional attention to detail  •    Experience in clinical trial data management  •    Knowledge of GCP  •    The ability to manage multiple priorities in a fast-paced environment

Main duties of the job

• Lead and line manage half the CRF data management team, including workload allocation, training, and day-to-day support  •    Oversee data management activities across a portfolio of complex clinical trials and experimental medicine studies  •    Responsible for managing vacancies, including shortlisting and interviewing •    Ensure timely and accurate completion of trial case report forms in accordance with ICH GCP, study protocols, and regulatory requirements.  •    Monitor data entry timelines and sponsor data queries, escalating and resolving issues promptly  •    Support preparation of study documentation for audits, monitoring visits, and regulatory inspections  •    Organise and host trial monitoring visits and attend Site Initiation Visits (SIVs) as required  •    Support SAE reporting  •    Develop and maintain study databases and trial worksheets  •    Assist the Quality Assurance Manager with internal audits, reviews, and portfolio performance management •    Work collaboratively with multidisciplinary research teams and communicate professionally with all trial stakeholders

The role requires flexible working across both CRF sites depending on service needs.

Detailed job description and main responsibilities

For the full Person Specification and more information regarding the main responsibilities of this role, please refer to the attached Job Description.

Come and be a part of the best NHS trust in England to work for, according to our staff*

* UCLH top trust to work at in England - In the most recent NHS staff survey UCLH had the highest percentage of staff who said they would recommend us as a place to work, out of all general acute or acute/community NHS trusts in England – for the third year in a row.

UCLH recognises the benefits of flexible working for staff – To find out more, visit: Flexible working.

To discover more about what makes UCLH a great place to work, visit: Why Choose UCLH?