Data Quality Manager

Our client is a truly international pharmaceutical company that carries out the research, development, manufacture and marketing of prescription pharmaceuticals. The innovative company is seeking a Data Quality Manager to join their team in Cambridge, UK.

Job Role:

The role of Data Quality Manager (DQM) is to be a member of the company study team accountable for the data quality of the studies assigned in Early Clinical Development. The DQM will give guidance in data management processes and related activities to the ECD study teams; provide expertise in data management as well as information on company standards, processes, systems and expectations to the vendor.

The role is key to enabling efficient, timely and high-quality data delivery, in close cooperation with the vendor. The DQM will also be involved in process development and improvement initiatives.

Job Responsibilities:

• Provide clinical data management support to internal study teams in early clinical development, and project support to the Data Management Expert (DME).
• Communicate frequently and provide the right level of support to the lead data manager and other relevant functions at the vendor
• Work within established frameworks to deliver a variety of tasks that support projects in meeting their objectives
• Actively participate in study team meetings and maintain awareness of the current status of the study
• Responsible for providing guidance on existing/new data standards
• Review of key clinical research documents (e.g. Study synopsis, Protocols, Case Report Forms, DMP, SAP etc)
• Provide support, guidance and expertise to Data management activities (e.g. electronic data capture, data transfer agreements, data transfer agreements, reconciliation issues.)
• Responsible for the data quality, risk mitigation and assessing solutions within studies
• Contribute to process development and improvement reviews, help define working practices and ensure non compliant processes are escalated

Minimum Requirements:

• BSc or post graduate qualification (or local equivalent) in computing, Life Sciences or equivalent experience
• At least 5 years data management and/or related work in pharmaceutical company or CRO
• Experience as a lead data manager
• Good knowledge of Clinical database applications such as EDC
• Good Knowledge of CDASH/Clinical data standards

Preferred Experience:

• TA Experience from Oncology, respiratory and cardiovascular
• Database Set up Experience of multiple trials
• Experience of vendor management
• Experience in Early phase trials
• CDISC knowledge
• Knowledge of EDC systems

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 contact Tom Magenis at t.magenis@Proclinical.com 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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