Global Data Manager

For our client located in the Netherlands, we are currently looking for a Global Data Manager.

Start: ASAP.
Duration: 6 months with possibility of extension
Work location: Tilburg/Turnhout (Belgium)
Project language: English

POSITION SUMMARY
* Accountable for the project management, complete oversight and timely delivery of clinical trial data and documentation according to agreed upon timelines and quality expectations
* Is the liaison between the trial customer, the CRO(s) and other functional partners(s) for all issues related to data for assigned trial(s).
* Ensures Inspection Readiness of all data management deliverables and ensures adequate archiving of data management documentation
* Is a member of SMT and Working Group(s) and leads the trial subteam(s)/workstream(s) for data management deliverables (eg, eCRF design, Database Lock)
* Participates in or leads a non-trial related project within IDS or cross functionally

PRINCIPAL RESPONSIBILITIES:
* Liaises continually between the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s)
* With the trial customer, CRO and other functional partners:
o Gathers content and integration requirements for eCRF and other data collection tools
o Establishes conventions and quality expectations for clinical data
o Establishes expectations for dataset content and structure
o Sets timeline and follow-up regularly to ensure delivery of all Data Management milestones
* Performs trial level oversight controls as described in the oversight plan, QC process and work instructions
* Prepares or reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency; ensures compliance with regulatory guidelines and the documentation Matrix
* Ensures Real Time inspection readiness of all IDS deliverables for the trial; Participates in Regulatory Agency and Client internal audits as necessary
* Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival; ensures deliverables are on time and within budget
* Supports the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met
* Provides input to the DML on trial initiation needs (scope of work, budget, resources), and CRO selection in non-standard situations as appropriate
* Identifies and communicates lessons learned, best practices and frequently asked questions at trial level
* Identifies and participates in process, system, and tool improvement initiatives within IDS
* Presents and trains at investigator and monitor meetings
* Participates in/or leads non-trial/non-program projects based on specific expertise

Personal skills
* Excellent communicator, process skills and being able to influence without hierarchical force.
* Convincing personality.
* Fluent in English and preferably fluent in DutchMichael Bailey International is acting as an Employment Business in relation to this vacancy.