Permanent

Lead Data Manager

Urgent
Posted 1 month ago
north carolina
£110,000 - £130,000 per year
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Job Description

Lead Data Manager

AL Solutions are working on behalf of an international Rare Disease Biotech company that are looking to expand their Biometrics team. We are looking to appoint a Lead Data Manager to support them, being based in North Carolina USA. This position can be worked with remote flexibility across the East Coast.

Our client has a very strong pipeline of clinical stage drugs, with recent approvals across the USA and Japan for one of their new products.

As a Lead Data Manager, you will be reporting into their Head of Statistical Programming + Data Management. You will be responsible for managing all aspects of the study data management process from start-up through to database lock and regulatory submission support. This role will entail liaising with CROs and external vendors as well as internal stakeholders.

Responsibilities

  • CRO selection and oversight
  • Ensure completeness and consistency of routine clinical data and its structure
  • Work closely with DM CRO to ensure all eCRFs, CCGs, Edit Checks, SOPs and DMPs meet study requirements and assist with updates as required
  • Assist with updates to the Medidata Rave EDC system
  • Meet timelines and project deliverables, by working closely with the CRO and internal teams
  • Close collaboration with Stats and Clinical teams to manage frequent DMC meetings
  • Aid study manager in managing and tracking database interim review and lock timelines
  • Support Study-level audit and inspection readiness activities as needed

Experience/Qualifications

  • 5+ years’ data management experience with the majority being within a Sponsor company (some CRO experience also valued)
  • Medidata RAVE experience
  • Experience in Phase II + III trials as the lead
  • Experience overseeing CROs
  • Autonomous & independent

Please apply to find out more, or check our website for more opportunities.