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Macclesfield, Cheshire Science and Research Posted 15.06.20 Negotiable

Lead Data Manager

The Benefits:

  • Competitive salary

  • Company performance-based bonus

  • On-site parking

  • Pension

  • Holiday benefit is 25 days’ holiday

  • Excellent on-site facilities and working environment

The Role:

As a Lead Data Manager you will be accepting this exciting opportunity to lead interesting, mainly early phase clinical trials. As a key member of the clinical study team, you will establish, perform and oversee the setup, maintenance, control and validation of clinical study databases ensuring compliance with Standard Operating Procedures and applicable regulatory guidelines at all times. There will also be the opportunity to contribute to the DM capability and processes to help shape this growing department in the current technology driven environment.

Specifically, you will:

  • Have a keen interest in digital technology and driving forward new and innovative technologies within the clinical setting.

  • Define and manage clinical data management timelines on multiple studies or programmes

  • Coordinate/perform all CDM activities for assigned studies/programmes, including eCRF design, EDC system set up, user acceptance testing, users training, data review, query generation and data coding

  • Prepare data management plans, data validation plans and other study specific procedures and guidelines in compliance with standard processes and SOPs

  • Ensure appropriate study specific training is provided to assigned clinical study teams

  • Generate data analysis status reports on clinical studies for the clinical study teams

About You:

To join us as a Lead Data Manager, you will need:

  • A scientific background, ideally university level and GCP trained

  • A minimum of 5 years’ experience in clinical data management at a CRO or Pharma with strong experience using major EDC systems and related tools and technologies

  • Experience in leading data management studies and teams to timely delivery of quality databases that meet regulatory requirements

  • Sound working knowledge of programming languages utilised in data management (e.g. javascript, SQL)

  • Knowledge and experience of using CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml

  • Good planning, organisational and communication skills

  • Excellent written and verbal English

  • Excellent attention to detail

Additionally, to be considered for our Lead Data Manager position, you will ideally have experience of using Viedoc EDC.

Cordant Group is an equal opportunities employer

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