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.
- 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
- 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.