Data Quality Manager in Melbourn, Cambridgeshire
CK Group is recruiting for a Data Quality Manager to join a company in the Pharmaceutical industry at their site based in Melbourn, Cambridgeshire, with the possibility of 1 to 2 days home working, on a 12 month contract basis.
The Company: Our client is a global pharmaceutical company with a large presence and multiple sites in the UK. They produce innovative medicines across a range of therapeutic areas to enhance the health and lives of their patients.
The Location: Located within the South East of England in Melbourn. Melbourn is a large village in the far south west of Cambridgeshire. It is located next to the A10 just north of Royston.
The Role: The role of Data Quality Manager (DQM) will be a member of the study team accountable for the data quality of the studies assigned in Early Clinical Development (ECD). 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 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. The DQM is responsible for the quality of their own work and will be expected to manage their own daily planning. High attention to detail and a strong analytical mind-set is essential.
Key Responsibilities include to:
- 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.
- Responsible for submitting any new/amended standards and request for LAB codes in line with ECD processes.
- 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, SDTM mapping, specific coding, data transfer agreements, reconciliation issues).
- Specialist in TA specific data capture and standards (oncology, respiratory and cardiovascular) and CDISC standards.
- 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 noncompliant processes are escalated.
Your Background: To succeed in this role you will have extensive experience working in data management within a pharmaceutical or CRO environment. You will have excellent knowledge of good clinical practice, Clinical research, Clinical trial processes and the related regulatory requirements and terminology as well as good knowledge of Clinical database applications such as EDC. Experience in Oncology, respiratory and/or cardiovascular areas would be an advantage. You will also have experience with SAS programing/mapping of data to SDTM and CDISK.
For more information or to apply for the Data Quality Manager position, please contact Natasha Young on 01246 457739 or email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45475 in all correspondence.