Data Quality Lead - Level 1

ProClinical is happy to advertise an opportunity for a Data Quality Lead/Clinical Data Scientist position with a top 10 global pharmaceutical company. This company offers leading products across various therapeutic areas and is looking to hire a Data Quality Lead/Clinical Data Scientist to join their team in Uxbridge.

The Data Quality Lead/Clinical Data Scientist will primarily assist the oversight of CRO, whilst providing expertise in data management throughout the whole lifecycle of a clinical trial, from database set-up to database lock.

Job Responsibilities:

• Defining, building, and testing databases (such as eCRF) and validation checks.
• Overseeing data entry and clean up, along with delivery of clean datasets for analysis and reporting.
• Leading study and project teams in the delivery of high-quality data to support the reporting of early phase pharmacology studies.
• Closely collaborating with investigational sites and monitors around the world in order to set up, conduct, and deliver on clinical trial data to the highest quality.
• Providing data management input to the protocol and translating the protocol into specifications for all data types.
• Utilising data visualisation tools to identify scientifically unfeasible or anomalous data and taking appropriate action to prevent or minimise reoccurrence.
• Partnering with the study team to responsible deliver data management contributions to regulatory submissions when required.
• Identifying, participating, and/or leading process improvement initiatives.
• Training, coaching, and mentoring staff as required.
• Completing of specific project goals and objectives in accordance with defined quality and time-based metrics.

Skills and Requirements:

• Demonstrable experience in either rare decisions, gene therapy, working with Academic Research Organisations (AROs), CDISC, and working with eDC tools (RAVE).
• Demonstrable leadership skills within a matrix environment, along with an ability to influence, persuade, and negotiate with stakeholders to identify solutions.
• Conversant with the clinical trial environment, study design, and the bigger picture of drug development.
• An ability to apply scientific knowledge, previous experience, and curiosity to identify risks to data integrity and implement mitigation plans to maximise data evaluability.
• High organised with an ability to prioritise work and remain focused on objectives in rapidly changing circumstances.
• Demonstrated effective oversight of outsourced activities.
• An ability to think outside the box within the confines of company procedures, along with industry and regulatory requirements.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Tom Magenis on +44 203 854 1050 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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