Project Manager - Clinical Data Standards

3 jours restants

Région
Beerse
Publication
vendredi 31 mars 2017
Date limite
dimanche 30 avril 2017
Réf
6A242XPE-BE
Contact
Andreea Ardelean
Fonction
Autre
Niveau d'expérience
5 à 10 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Project Manager - Clinical Data Standards Organisation description:

XPE Pharma & Science is looking for a Project Manager - Clinical Data Standards. Proven working experience as a Project Manager in the pharmaceutical industry is required, especially clinical development. Solid background in clinical data management, biostatistics or statistical programming is an asset. In-depth knowledge of the CDISC standards is mandatory.

Job description:

Project definition

The Standards and Metadata project holds the following work streams:

• Define.xml 2.0: On March 15, 2018, FDA will stop the support of define.xml 1.0. All trials started after that date need to be submitted with the CDISC define.xml 2.0 version. The objective of this work stream is to implement the capabilities required to deliver define.xml 2.0 in support of the SDTM and ADaM datasets submitted to the FDA. PMDA has very similar requirements.

• Metadata Management: The objective of this work stream is to implement the capabilities required to manage standard and trial level metadata and to enable consumption of this metadata. In addition, this work stream will need to deliver a new proprietary metadata model (incl. model definition, implementation and roll-out).

• Data Conversion: The objective of this work stream is to implement the capabilities required to support data conversion from raw input data into several output formats (incl. SDTM).


This project needs to look at processes, technology and standards in support of the above work streams. On top these capabilities need to support the various sourcing models: in-house resourcing, functional outsourcing and strategic outsourcing.


Project Management responsibilities

• Develop a comprehensive and complete project plan to meet the project deliverables and milestones

• Execute successfully against the project plan

o Coordinate internal resources and third parties/vendors for the flawless execution of projects

o Coordinate and manage dependencies with other ongoing projects

o Coordinate and manage dependencies with drug development programs

o Coordinate and manage dependencies with new version of industry standards and guidelines

o Ensure that all deliverables are on-time, within scope and within budget

o Ensure resource availability and allocation

o Report progress against project plan

o Manage effectively changes in project scope, schedule and costs

o Measure project performance using appropriate systems, tools and techniques

o Report and escalate to management as needed

o Perform risk management to minimize project risks

o Create and maintain comprehensive project documentation

Profile:

• Proven working experience as a project manager in the pharmaceutical industry, specifically clinical development

• Solid background in clinical data management, biostatistics or statistical programming

• Good understanding of the CDISC standards (CDASH, SDTM, ADaM, define.xml, Controlled terminology)

• Excellent written and verbal communication skills

• Solid organizational skills including attention to detail and multi-tasking skills

• Strong working knowledge of Microsoft Office and Microsoft Project.

Offer:
  • Open end contract on XPE payroll;
  • Highly professional working environment.


Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713