Remote UK Senior Clinical Data Lead (CDISC, EDC/Veeva)

AL Solutions; United Kingdom; A distancia; GBP 70.000 - 100.000; Jornada completa

Descripción de la vacante

AL Solutions is seeking a Senior Clinical Data Manager in the United Kingdom to lead end-to-end data management on an FSP project for an international pharmaceutical sponsor within the Neurology & GI unit. The role is remote from the UK with flexible start dates.

You will act as the primary data lead in cross-functional study teams, oversee start-up activities (EDC build, UAT, system integrations), data review, data reconciliation, vendor oversight and database lock readiness, while ensuring

Formación

• Proven track record working in data management within clinical trials.
• Previous experience independently leading studies.
• Knowledge of CDISC standards.
• Strong understanding of the clinical trial process, regulatory requirements, and ICH-GCP.
• Strong hands-on experience with EDC systems (Veeva preferred).

Responsabilidades

• Act as the primary data lead within cross-functional study teams
• Lead study start-up activities by coordinating EDC build & configuration, system integrations, user acceptance testing (UAT), and the timely completion of key data management milestones.
• Manage ongoing data review processes, reconciliation activities, vendor oversight, and database lock readiness to maintain data quality and study timelines.
• Maintained adherence to CDISC standards, ICH-GCP guidelines, and applicable regulatory requirements throughout the clinical trial lifecycle.
• Proactively assess and address project risks while implementing process improvements to enhance operational efficiency and overall data management quality.

Conocimientos

Data management

Clinical trials

CDISC

Veeva

Regulatory knowledge

Educación

Bachelor's in life sciences

Herramientas

Veeva

Descripción del empleo

AL Solutions is seeking a Senior Clinical Data Manager in the United Kingdom to lead end-to-end data management on an FSP project for an international pharmaceutical sponsor within the Neurology & GI unit. The role is remote from the UK with flexible start dates.

You will act as the primary data lead in cross-functional study teams, oversee start-up activities (EDC build, UAT, system integrations), data review, data reconciliation, vendor oversight and database lock readiness, while ensuring