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Data Manager - Cambridge

Company: Hays Resource Management - Astrazeneca
Job type: contract
Category: Research

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Job description

We are recruiting for a Contract Data Manager to cover secondment of a Data manager Expert (DME) in Early Clinical Development - 6 months. The Role will require occasional working in Cambridge but the majority will be remote working. The Role will provide support and guidance within data management processes and related activties for ECD within defined vendor models. To provide expertise on data management to projects teams and vendors, input into AZ standards and ensure quality deliverables from vendors.

Experience required:

Experienced background in operational Data management with at least 6 years' experience:- Led multiple studies at the same time or a large phase III study (required)
- Data review/data validation tasks (required)
- Development of Data Management documentation (required)
- Experience of reviewing clinical research documentation (required)
- Electronic Data Capture experience (required)

Experience in Early clinical Studies, Phase 1 and 2 in Oncology and or respiratory/Cardiovascular TA standards (CDASH and SDTM)- Experience in Early Clinical (phase I and II) studies (preferred)
- Oncology experience (required)
- Cardiovascular experience (preferred)
- Respiratory experience (preferred)
- Standards experience (required)
- SDTM knowledge (preferred)

Excellent communication/project management skills, with experience in the following:- Working cross-functionally (required)
- Communicating with different stakeholders within a project (required)
- Communicating with external stakeholders (preferred)
- Leading a project/work stream (preferred)

Experience of leading DM activities within outsourcing models- Experience and understanding of sponsor/CRO collaboration (required)
- Awareness of different data management terminology and processes (preferred)

Excellent knowledge of GCP, GMP and Clinical research- Excellent knowledge of GCP (required)
- Knowledge of GMP (preferred)
- Excellent knowledge of the clinical development process (required)
- Knowledge of regulatory requirements and terminology (required)

Hays Talent Solutions is a trading division of Hays Specialist Recruitment Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T and C's, Privacy Policy and Disclaimers which can be found on our website.

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