Interim Senior Data Manager

You will be leading and coordinating data-management activities at the study and project level, delivering to the agreed quality, timelines and budget. You ensure data management activities across the project are consistent and to agreed standards including ICH GCP, regulations, SOPs and CDISC to support MAA and BLA submissions.

We are a great team of 30 people, all seasoned professionals, working hard to bring our product to patients.  We work either at our office in Leiden, or  remote.  We love the scale-up vibe: can-do mentality and pragmatic.

You will ensure effective oversight of oursourced data management activities and deliverables. 

Project data management, working with study data managers to ensure consistency across the project and co-ordinating data management contributions for MAA, BLA submissions. 

Ensure TMF for data management at the study and project level is in a state of audit readiness at all times. 

demonstrated proficiency in CDISC standards, ICH GCP and regulatory requirements.

Proven experience with a range of data management software and data acquisition tools (e.g. medidata RAVE).

This is an assignment for 12 months. You will work remote or based form our office in Leiden (the Netherlands).

You need to have experience in a similar role on the sponsor side, preferably as well on the CRO side. Life science experience is a must.  Please indicate your availability (as of when and how many hours a week) and your hourly/daily rate